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Clinical Trial Results:
A 6-Month, Open-Label, Multi-Center, Flexible-Dose Extension Study to the B2061032 Study to Evaluate the Safety, Tolerability and Efficacy of Desvenlafaxine Succinate Sustained-Release (DVS SR) Tablets in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder

Summary
EudraCT number	2008-001876-67
Trial protocol	Outside EU/EEA
Global end of trial date	22 Apr 2016

Results information
Results version number	v1(current)
This version publication date	03 Nov 2016
First version publication date	03 Nov 2016
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

B2061030

ISRCTN number

US NCT number

NCT01371708

WHO universal trial number (UTN)

Other trial identifiers

Alias ID: 3151A6-3344

Sponsor organisation name

Pfizer, Inc.

Sponsor organisation address

235 E 42nd Street, New York, United States, NY 10017

Public contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Scientific contact

Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Yes

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

22 Apr 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Apr 2016

Global end of trial reached?

Yes

Global end of trial date

22 Apr 2016

Was the trial ended prematurely?

Main objective of the trial

This Phase 3, multi-center, open-label, flexible-dose extension study of desvenlafaxine succinate sustained-release (DVS SR) in the treatment of child (7 to 11 years of age) and adolescent (12 to 17 years of age) outpatients with Major Depressive Disorder (MDD) who completed the preceding double-blind study (B2061032) aimed to evaluate the long-term safety, tolerability and efficacy of DVS SR in the treatment of children and adolescents with MDD.

Protection of trial subjects

This study was conducted in compliance with the ethical principles originating in or derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonisation Good Clinical Practice Guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol and any amendments were reviewed and approved by the Institutional Review Board(s) and/or Independent Ethics Committee(s) at each of the investigational centres participating in the study.

Background therapy

Evidence for comparator

Actual start date of recruitment

02 Feb 2012

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 282

Country: Number of subjects enrolled

Chile: 1

Worldwide total number of subjects

283

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

196

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Participants completing study B2061032 who, in the Investigator’s opinion, would benefit from long-term treatment with DVS SR, may have been eligible for this extension study. Of the 304 participants completing study B2061032, 283 transitioned to this study at the Week 8 visit of the preceding double-blind study. Of these, 281 received treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Placebo/DVS-SR

Arm description

Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Arm type

Experimental

Investigational medicinal product name

Desvenlafaxine succinate sustained-release

Investigational medicinal product code

Other name

DVS SR

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received placebo in the previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

DVS-SR, low dose/DVS-SR

Arm description

Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Arm type

Experimental

Investigational medicinal product name

Desvenlafaxine succinate sustained-release

Investigational medicinal product code

Other name

DVS SR

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received DVS SR in weight based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

DVS-SR, high dose/DVS-SR

Arm description

Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Arm type

Experimental

Investigational medicinal product name

Desvenlafaxine succinate sustained-release

Investigational medicinal product code

Other name

DVS SR

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received DVS SR in weight based dosing (20, 25, or 50 mg) in previous study B2061032, and DVS SR in this extension study B2061030 in a flexible dosing regimen (20, 25, 35, or 50 mg/day as clinically indicated) of up to 26 weeks, followed by a taper phase of up to 2 weeks.

Number of subjects in period 1	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Started	92	93	98
Received treatment	91	93	97
Completed	66	63	59
Not completed	26	30	39
Adverse event, non-fatal	5	8	12
Not specified	3	2	4
No longer willing to participate	7	7	13
Started study but did not receive study treatment	1	-	1
Lost to follow-up	5	9	7
Medication error/not related to AE	-	1	-
Insufficient clinical response	3	2	-
Protocol deviation	2	1	2

Baseline characteristics

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Reporting group title

Placebo/DVS-SR

Reporting group description

Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, low dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, high dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR	Total
Number of subjects	92	93	98	283
Age, Customized
Units: Participants
2 to 11 years	28	26	33	87
12 to 17 years	64	67	65	196
Gender, Male/Female
Units: Participants
Female	43	52	61	156
Male	49	41	37	127

End points

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Reporting group title

Placebo/DVS-SR

Reporting group description

Participants received placebo tablets in previous study B2061032 and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, low dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, high dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Subject analysis set title

Combination Group

Subject analysis set type

Full analysis

Subject analysis set description

Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.

Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)

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End point title

Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) ^[1]

End point description

A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period. Analysis population included all participants who received at least 1 dose of study drug in study B2061030.

End point type

Primary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned for this primary endpoint

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	91	93	97
Units: Percentage of participants
number (not applicable)	78	73.1	71.1

No statistical analyses for this end point

Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)

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End point title

Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group) ^[2]

End point description

End point type

Primary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical analyses was planned for this primary endpoint

End point values	Combination Group
Number of subjects analysed	281
Units: Percentage of participants
number (not applicable)	74

No statistical analyses for this end point

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases

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End point title

Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases

End point description

The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	63	57	56
Units: Units on a scale
arithmetic mean (standard deviation)	-6.79 ± 12.05	-10.72 ± 10.8	-8.57 ± 13.01

No statistical analyses for this end point

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)

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End point title

Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)

End point description

The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Combination Group
Number of subjects analysed	176
Units: Units on a scale
arithmetic mean (standard deviation)	-8.63 ± 12.03

No statistical analyses for this end point

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

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End point title

Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

End point description

The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	63	57	56
Units: Units on a scale
arithmetic mean (standard deviation)	-1.02 ± 1.18	-1.44 ± 1.12	-0.7 ± 1.37

No statistical analyses for this end point

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

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End point title

Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

End point description

The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating “normal, not at all ill” and 7, “among the most extremely ill patients.” Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Combination Group
Number of subjects analysed	176
Units: Units on a scale
arithmetic mean (standard deviation)	-1.05 ± 1.26

No statistical analyses for this end point

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases

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End point title

Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases

End point description

The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & impact of symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	63	57	56
Units: Percentage of participants
number (not applicable)	87.3	94.7	89.3

No statistical analyses for this end point

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)

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End point title

Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)

End point description

The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & impact of symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, & the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, & were available for evaluation.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Combination Group
Number of subjects analysed	176
Units: Percentage of participants
number (not applicable)	90.3

No statistical analyses for this end point

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases

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End point title

Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases

End point description

The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	63	57	56
Units: Percentage of participants
number (not applicable)
Week 26: Very much improved	54	73.7	53.6
Week 26: Much improved	33.3	21.1	35.7
Week 26: Minimally improved	9.5	5.3	10.7
Week 26: No change	1.6	0	0
Week 26: Minimally worse	1.6	0	0
Week 26: Much worse	0	0	0
Week 26: Very much worse	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)

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End point title

Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)

End point description

The CGI Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, & the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used to assess improvement in a patient's illness relative to baseline. Scores range from 1 (“very much improved”) to 7 (“very much worse”); a value of 0 = not assessed. A response on the CGI-I scale is defined as a CGI-I score of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032. Analysis population included all participants with a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, & were available for evaluation.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Combination Group
Number of subjects analysed	176
Units: Percentage of participants
number (not applicable)
Week 26: Very much improved	60.2
Week 26: Much improved	30.1
Week 26: Minimally improved	8.5
Week 26: No change	0.6
Week 26: Minimally worse	0.6
Week 26: Much worse	0
Week 26: Very much worse	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases

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End point title

Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases

End point description

Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, and had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Placebo/DVS-SR	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Number of subjects analysed	63	57	56
Units: Percentage of participants
number (not applicable)	73	89.5	75

No statistical analyses for this end point

Secondary: Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)

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End point title

Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)

End point description

Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms. Analysis population included all participants who had a CDRS-R evaluation at Baseline of study B2061030 (Week 8 of study B2061032), took at least 1 dose of study drug, had at least 1 CDRS-R evaluation after the first dose of study drug in B2061030, and were available for evaluation.

End point type

Secondary

End point timeframe

From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

End point values	Combination Group
Number of subjects analysed	176
Units: Percentage of participants
number (not applicable)	79

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

From informed consent through Week 30 (adverse events) and Week 32 visit (serious adverse events). For participants who discontinued prior to Week 28 visit: Adverse events collected for 14 days, and serious adverse events for 28 days,

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Placebo/DVS-SR

Reporting group description

Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

Combination Group

Reporting group description

Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, low dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Reporting group title

DVS-SR, high dose/DVS-SR

Reporting group description

Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.

Serious adverse events	Placebo/DVS-SR	Combination Group	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 91 (4.40%)	13 / 281 (4.63%)	6 / 93 (6.45%)	3 / 97 (3.09%)
number of deaths (all causes)	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	0 / 93 (0.00%)	1 / 97 (1.03%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Generalised tonic-clonic seizure
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Aggression
subjects affected / exposed	1 / 91 (1.10%)	1 / 281 (0.36%)	0 / 93 (0.00%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Agitation
subjects affected / exposed	1 / 91 (1.10%)	2 / 281 (0.71%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 1	1 / 2	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hallucination, auditory
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Initial insomnia
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Major depression
subjects affected / exposed	1 / 91 (1.10%)	1 / 281 (0.36%)	0 / 93 (0.00%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Pyromania
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	2 / 91 (2.20%)	5 / 281 (1.78%)	1 / 93 (1.08%)	2 / 97 (2.06%)
occurrences causally related to treatment / all	0 / 2	2 / 5	1 / 1	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Suicide attempt
subjects affected / exposed	0 / 91 (0.00%)	3 / 281 (1.07%)	2 / 93 (2.15%)	1 / 97 (1.03%)
occurrences causally related to treatment / all	0 / 0	4 / 4	3 / 3	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Suicide threat
subjects affected / exposed	1 / 91 (1.10%)	1 / 281 (0.36%)	0 / 93 (0.00%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Ketoacidosis
subjects affected / exposed	0 / 91 (0.00%)	1 / 281 (0.36%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 3%

Non-serious adverse events	Placebo/DVS-SR	Combination Group	DVS-SR, low dose/DVS-SR	DVS-SR, high dose/DVS-SR
Total subjects affected by non serious adverse events
subjects affected / exposed	60 / 91 (65.93%)	175 / 281 (62.28%)	57 / 93 (61.29%)	58 / 97 (59.79%)
Investigations
Weight increased
subjects affected / exposed	5 / 91 (5.49%)	14 / 281 (4.98%)	4 / 93 (4.30%)	5 / 97 (5.15%)
occurrences all number	5	14	4	5
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	8 / 91 (8.79%)	20 / 281 (7.12%)	4 / 93 (4.30%)	8 / 97 (8.25%)
occurrences all number	12	29	7	10
Ligament sprain
subjects affected / exposed	3 / 91 (3.30%)	3 / 281 (1.07%)	0 / 93 (0.00%)	0 / 97 (0.00%)
occurrences all number	3	3	0	0
Nervous system disorders
Dizziness
subjects affected / exposed	4 / 91 (4.40%)	15 / 281 (5.34%)	6 / 93 (6.45%)	5 / 97 (5.15%)
occurrences all number	4	18	7	7
Headache
subjects affected / exposed	12 / 91 (13.19%)	45 / 281 (16.01%)	16 / 93 (17.20%)	17 / 97 (17.53%)
occurrences all number	19	79	29	31
Psychomotor hyperactivity
subjects affected / exposed	3 / 91 (3.30%)	4 / 281 (1.42%)	1 / 93 (1.08%)	0 / 97 (0.00%)
occurrences all number	4	5	1	0
Somnolence
subjects affected / exposed	10 / 91 (10.99%)	14 / 281 (4.98%)	3 / 93 (3.23%)	1 / 97 (1.03%)
occurrences all number	10	14	3	1
General disorders and administration site conditions
Fatigue
subjects affected / exposed	3 / 91 (3.30%)	6 / 281 (2.14%)	0 / 93 (0.00%)	3 / 97 (3.09%)
occurrences all number	3	6	0	3
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	4 / 91 (4.40%)	13 / 281 (4.63%)	1 / 93 (1.08%)	8 / 97 (8.25%)
occurrences all number	4	17	1	12
Constipation
subjects affected / exposed	0 / 91 (0.00%)	3 / 281 (1.07%)	0 / 93 (0.00%)	3 / 97 (3.09%)
occurrences all number	0	3	0	3
Diarrhoea
subjects affected / exposed	2 / 91 (2.20%)	8 / 281 (2.85%)	1 / 93 (1.08%)	5 / 97 (5.15%)
occurrences all number	3	9	1	5
Nausea
subjects affected / exposed	4 / 91 (4.40%)	21 / 281 (7.47%)	11 / 93 (11.83%)	6 / 97 (6.19%)
occurrences all number	5	25	11	9
Vomiting
subjects affected / exposed	6 / 91 (6.59%)	12 / 281 (4.27%)	2 / 93 (2.15%)	4 / 97 (4.12%)
occurrences all number	7	16	2	7
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	1 / 91 (1.10%)	4 / 281 (1.42%)	0 / 93 (0.00%)	3 / 97 (3.09%)
occurrences all number	1	4	0	3
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	2 / 91 (2.20%)	5 / 281 (1.78%)	3 / 93 (3.23%)	0 / 97 (0.00%)
occurrences all number	2	5	3	0
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 91 (0.00%)	5 / 281 (1.78%)	2 / 93 (2.15%)	3 / 97 (3.09%)
occurrences all number	0	5	2	3
Attention deficit/hyperactivity disorder
subjects affected / exposed	3 / 91 (3.30%)	6 / 281 (2.14%)	1 / 93 (1.08%)	2 / 97 (2.06%)
occurrences all number	3	6	1	2
Depression
subjects affected / exposed	1 / 91 (1.10%)	8 / 281 (2.85%)	3 / 93 (3.23%)	4 / 97 (4.12%)
occurrences all number	1	8	3	4
Initial insomnia
subjects affected / exposed	5 / 91 (5.49%)	6 / 281 (2.14%)	0 / 93 (0.00%)	1 / 97 (1.03%)
occurrences all number	5	6	0	1
Insomnia
subjects affected / exposed	7 / 91 (7.69%)	17 / 281 (6.05%)	6 / 93 (6.45%)	4 / 97 (4.12%)
occurrences all number	8	18	6	4
Irritability
subjects affected / exposed	3 / 91 (3.30%)	14 / 281 (4.98%)	4 / 93 (4.30%)	7 / 97 (7.22%)
occurrences all number	3	15	5	7
Self injurious behaviour
subjects affected / exposed	0 / 91 (0.00%)	4 / 281 (1.42%)	3 / 93 (3.23%)	1 / 97 (1.03%)
occurrences all number	0	4	3	1
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	3 / 91 (3.30%)	7 / 281 (2.49%)	2 / 93 (2.15%)	2 / 97 (2.06%)
occurrences all number	4	10	2	4
Infections and infestations
Gastroenteritis
subjects affected / exposed	3 / 91 (3.30%)	6 / 281 (2.14%)	2 / 93 (2.15%)	1 / 97 (1.03%)
occurrences all number	3	6	2	1
Gastroenteritis viral
subjects affected / exposed	7 / 91 (7.69%)	16 / 281 (5.69%)	3 / 93 (3.23%)	6 / 97 (6.19%)
occurrences all number	7	16	3	6
Nasopharyngitis
subjects affected / exposed	9 / 91 (9.89%)	21 / 281 (7.47%)	4 / 93 (4.30%)	8 / 97 (8.25%)
occurrences all number	10	23	5	8
Otitis media
subjects affected / exposed	3 / 91 (3.30%)	5 / 281 (1.78%)	1 / 93 (1.08%)	1 / 97 (1.03%)
occurrences all number	3	5	1	1
Pharyngitis streptococcal
subjects affected / exposed	1 / 91 (1.10%)	5 / 281 (1.78%)	1 / 93 (1.08%)	3 / 97 (3.09%)
occurrences all number	1	5	1	3
Sinusitis
subjects affected / exposed	1 / 91 (1.10%)	8 / 281 (2.85%)	2 / 93 (2.15%)	5 / 97 (5.15%)
occurrences all number	1	9	2	6
Upper respiratory tract infection
subjects affected / exposed	4 / 91 (4.40%)	16 / 281 (5.69%)	10 / 93 (10.75%)	2 / 97 (2.06%)
occurrences all number	5	19	11	3
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	4 / 91 (4.40%)	7 / 281 (2.49%)	2 / 93 (2.15%)	1 / 97 (1.03%)
occurrences all number	4	7	2	1
Increased appetite
subjects affected / exposed	0 / 91 (0.00%)	4 / 281 (1.42%)	3 / 93 (3.23%)	1 / 97 (1.03%)
occurrences all number	0	4	3	1

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Were there any global substantial amendments to the protocol? Yes

13 Jul 2011

Clarified that no repackaging or labeling of the study drug containers that obscured the Pfizer label was permitted at the sites. Deleted investigational procedures from the prohibited treatment list. Text revised to clarify participants who were required to sign an informed consent document were those reaching the age of majority rather than reaching the age of 18 years. Addition of methaqualone to the urine drug screen testing list. Added the 10 mg/day dose blister card to the table in Appendix 1 of the protocol.

22 May 2013

Updates/clarifications to Schedule of Activities. Adult studies in introduction revised. Combined & clarified efficacy endpoints. Permitted omission of taper& exclusion of extension. Updated study duration. Inclusion criteria: 2: changed “legally acceptable representative” to “legal guardian”; 4, 5 & 6: clarified contraception requirements. Exclusion criteria: 1: deleted “potential child or adolescent”; 2: renamed “study drug” to “investigational product”; 4: clarified exclusion of participants requiring prohibited medication; 6: clarified history of suicide behavior exclusion since last visit, added risk assessment; 7: clarified suicidal ideation exclusion since last visit, added risk assessment. Added sections on sponsor qualified medical personnel, rater qualifications, & medication errors. Revised text for storage requirements. Clarified examples & use of permitted & prohibited concomitant treatments. Clarified review of results prior to randomisation. Clarified participant withdrawal, process for lost to follow-up, & added risk assessment. Clarified assessments for AEs/SAEs, vital signs, pregnancy testing, microscopic analysis, urine drug screen & comprehensive psychiatric evaluation. Revised text on guidance materials & clarified rater requirements/training. Added requirements for risk assessment & discontinuation following C-SSRS; evaluations. Clarified AE follow-up, serious versus non-serious AEs, timeframes for reporting, AE examples, defined significant disability/incapacity, protocol-specific SAEs, Hy’s Law criteria, causality assessment definition, reporting of exposures in utero, & source for AE information. Clarified the DMC responsibilities, Pfizer record retention policy, participant de-identification information, informed consent process & Pfizer communication of results. Added vendor information. Deleted End of Trial in a Member State section. Added table of diagnostician & rater requirements.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)

Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)

Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)

Primary: Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)

Secondary: Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

Secondary: Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)

Secondary: Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)

Secondary: Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)

Secondary: Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases

Secondary: Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases

Secondary: Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)

Secondary: Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)

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