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Clinical Trial Results:
A Double-blind, Placebo-Controlled Study of Cariprazine as Adjunctive Therapy in Major Depressive Disorder

Summary
EudraCT number	2011-005179-18
Trial protocol	FI EE SK SE
Global end of trial date	12 Dec 2013

Results information
Results version number	v1(current)
This version publication date	18 Apr 2018
First version publication date	18 Apr 2018
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

RGH-MD-75

ISRCTN number

-

US NCT number

NCT01469377

WHO universal trial number (UTN)

-

Sponsor organisation name

Forest Laboratories, LLC, an Allergan Affiliate

Sponsor organisation address

5 Giralda Farms, Madison, United States, NJ 07940

Public contact

Clinical Trials Registry Team, Allergan plc, 001 877‐277‐8566, IR-CTRegistration@allergan.com

Scientific contact

Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.com

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

No

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

No

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

No

Analysis stage

Final

Date of interim/final analysis

12 Dec 2013

Is this the analysis of the primary completion data?

No

Global end of trial reached?

Yes

Global end of trial date

12 Dec 2013

Was the trial ended prematurely?

No

Main objective of the trial

The main objectives of this study were to evaluate the efficacy, safety, and tolerability of cariprazine adjunctive to antidepressant therapy (ADT) in subjects with major depressive disorder (MDD) who had an inadequate response to ADT.

Protection of trial subjects

All study subjects were required to read and sign an Informed Consent Form.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

15 Dec 2011

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Estonia: 109

Country: Number of subjects enrolled

Finland: 76

Country: Number of subjects enrolled

Slovakia: 81

Country: Number of subjects enrolled

Sweden: 25

Country: Number of subjects enrolled

Ukraine: 60

Country: Number of subjects enrolled

United States: 468

Worldwide total number of subjects

819

EEA total number of subjects

291

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

807

From 65 to 84 years

12

85 years and over

0

Subject disposition

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Recruitment details

-

Screening details

A total of 1248 subjects were screened for eligibility, 819 subjects were randomized to receive double-blind treatment, 812 subjects received at least 1 dose of double-blind treatment (Safety Population), and 808 subjects had at least 1 postbaseline MADRS assessment [intent to treat (ITT) Population].

Number of subjects started

819

Number of subjects completed

812

Reason: Number of subjects

Randomized; Did Not Receive Study Drug: 7

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects received matched placebo capsules, orally, once daily for 8 weeks.

Cariprazine 1-2 mg

Arm description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Arm type

Experimental

Investigational medicinal product name

Cariprazine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects received cariprazine (1-2 mg/day) capsules, orally, once daily for 8 weeks.

Cariprazine 2-4.5 mg

Arm description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Arm type

Experimental

Investigational medicinal product name

Cariprazine

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Subjects received cariprazine (2-4.5 mg/day) capsules, orally, once daily for 8 weeks.

Number of subjects in period 1 ^[1]	Placebo	Cariprazine 1-2 mg	Cariprazine 2-4.5 mg
Started	266	273	273
Completed	234	226	210
Not completed	32	47	63
Withdrawal of Consent	11	13	14
Protocol Deviation	6	10	9
Adverse event, non-fatal	8	18	36
Lost to follow-up	2	2	4
Other Miscellaneous Reasons	2	-	-
Insufficient Therapeutic Response	3	4	-

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: Baseline Period is based on the Safety Population, that included all randomized participants who received at least 1 dose of investigational product. 7 participants did not receive study drug and are excluded.

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Cariprazine 1-2 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Cariprazine 2-4.5 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group values	Placebo	Cariprazine 1-2 mg	Cariprazine 2-4.5 mg	Total
Number of subjects	266	273	273	812
Age categorical
Units: Subjects
18 - 64 years	259	270	272	801
65 - 84 years	7	3	1	11
Age Continuous
Units: years
arithmetic mean (standard deviation)	46.4 ± 11.6	45.5 ± 11.9	45.1 ± 11.4	-
Gender, Male/Female
Units: Subjects
Female	190	187	201	578
Male	76	86	72	234
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	14	17	22	53
Not Hispanic or Latino	252	256	251	759
Unknown or Not Reported	0	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	2	1	1	4
Asian	1	4	4	9
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	32	31	24	87
White	230	234	242	706
More than one race	0	0	0	0
Unknown or Not Reported	1	3	2	6
Body Mass Index (BMI)
Units: kg/m^2
arithmetic mean (standard deviation)	28.93 ± 5.09	28.21 ± 5.51	29.05 ± 5.59	-
Waist Circumference
Units: cm
arithmetic mean (standard deviation)	94.32 ± 13.44	93.36 ± 14.20	94.91 ± 14.66	-
Weight
Units: kg
arithmetic mean (standard deviation)	81.53 ± 16.19	79.69 ± 16.31	82.17 ± 17.37	-

End points

Top of page

Reporting group title

Placebo

Reporting group description

Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Cariprazine 1-2 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Cariprazine 2-4.5 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Primary: Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 8

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End point title

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 8

End point description

The Montgomery-Åsberg Depression Rating Scale is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

End point type

Primary

End point timeframe

Baseline to Week 8

End point values	Placebo	Cariprazine 1-2 mg	Cariprazine 2-4.5 mg
Number of subjects analysed	264	273	271
Units: Units on a scale
least squares mean (standard error)	-12.5 ± 0.5	-13.4 ± 0.5	-14.6 ± 0.6

Cariprazine 1-2 mg vs Placebo

Comparison groups

Placebo v Cariprazine 1-2 mg

Number of subjects included in analysis

537

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2404 ^[1]

Method

Mixed-effect model for repeated measures

Parameter type

Least squares mean difference

Point estimate

-0.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.4

upper limit

0.6

Notes
[1] - p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.

Cariprazine 2-4.5 mg vs Placebo

Comparison groups

Placebo v Cariprazine 2-4.5 mg

Number of subjects included in analysis

535

Analysis specification

Pre-specified

Analysis type

P-value

= 0.0114 ^[2]

Method

Mixed-effect model for repeated measures

Parameter type

Least squares mean difference

Point estimate

-2.2

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

-0.6

Notes
[2] - p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.

Secondary: Change From Baseline in the Sheehan Disability Scale Total Score at Week 8

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End point title

Change From Baseline in the Sheehan Disability Scale Total Score at Week 8

End point description

The Sheehan Disability Scale measures an individual’s perception of the extent to which his or her emotional symptoms are disrupting his or her functioning in 3 domains, work/school, social life/leisure activities, and family life/home responsibilities. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement.

End point type

Secondary

End point timeframe

Baseline to Week 8

End point values	Placebo	Cariprazine 1-2 mg	Cariprazine 2-4.5 mg
Number of subjects analysed	264	273	271
Units: Units on a scale
least squares mean (standard error)	-6.6 ± 0.5	-7.7 ± 0.5	-8.0 ± 0.5

Cariprazine 1-2 mg vs Placebo

Comparison groups

Placebo v Cariprazine 1-2 mg

Number of subjects included in analysis

537

Analysis specification

Pre-specified

Analysis type

P-value

= 0.2404 ^[3]

Method

Mixed-effect model for repeated measures

Parameter type

Least squares mean difference

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

0.3

Notes
[3] - p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.

Cariprazine 2-4.5 mg vs Placebo

Comparison groups

Placebo v Cariprazine 2-4.5 mg

Number of subjects included in analysis

535

Analysis specification

Pre-specified

Analysis type

P-value

= 0.114 ^[4]

Method

Mixed-effect model for repeated measures

Parameter type

Least squares mean difference

Point estimate

-1.4

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

0

Notes
[4] - p-values were from an mixed-effects model for repeated measures with treatment group, pooled study center, visit, and treatment-group-by-visit interaction as fixed effects and the baseline value and baseline value-by-visit interaction as covariates.

Adverse events

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Timeframe for reporting adverse events

Adverse Events were collected and recorded from the time the participant signs the informed consent form until 30 days after the last dose of treatment.

Adverse event reporting additional description

Safety population: All randomized participants who received at least 1 dose of treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Cariprazine 1-2 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2 and 1.0 mg on Days 3-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 1.0 or 1.5 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 1.0, 1.5, or 2.0 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Placebo

Reporting group description

Participants received placebo orally once a day for 8 weeks. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Reporting group title

Cariprazine 2-4.5 mg

Reporting group description

Participants received cariprazine orally once a day for 8 weeks. Participants received cariprazine 0.5 mg on Days 1 and 2, 1.0 mg on Day 3, 1.5 mg on Day 4, and 2.0 mg on Days 5-7. At the investigator’s discretion dose levels could be increased during Week 2. Dose levels allowed during Week 2 were 2.0 or 3.0 mg. A second dose increase was allowed starting at Week 3. Dose levels allowed during Week 3 and the remainder of the treatment period were 2.0, 3.0, or 4.5 mg. Each participant continued to take the same dose of antidepressant therapy (bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, or vilazodone) the participant was receiving prior to entering this study throughout treatment.

Serious adverse events	Cariprazine 1-2 mg	Placebo	Cariprazine 2-4.5 mg
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 273 (0.00%)	1 / 266 (0.38%)	3 / 273 (1.10%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Cardiac disorders
Myocardial ischemia
subjects affected / exposed	0 / 273 (0.00%)	0 / 266 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	0 / 273 (0.00%)	0 / 266 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 273 (0.00%)	0 / 266 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 273 (0.00%)	0 / 266 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Panic attack
subjects affected / exposed	0 / 273 (0.00%)	0 / 266 (0.00%)	1 / 273 (0.37%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Depression
subjects affected / exposed	0 / 273 (0.00%)	1 / 266 (0.38%)	0 / 273 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Cariprazine 1-2 mg	Placebo	Cariprazine 2-4.5 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	121 / 273 (44.32%)	102 / 266 (38.35%)	179 / 273 (65.57%)
Nervous system disorders
Akathisia
subjects affected / exposed	18 / 273 (6.59%)	6 / 266 (2.26%)	61 / 273 (22.34%)
occurrences all number	26	6	80
Dizziness
subjects affected / exposed	10 / 273 (3.66%)	7 / 266 (2.63%)	14 / 273 (5.13%)
occurrences all number	10	9	17
Headache
subjects affected / exposed	24 / 273 (8.79%)	36 / 266 (13.53%)	24 / 273 (8.79%)
occurrences all number	31	45	30
Somnolence
subjects affected / exposed	24 / 273 (8.79%)	14 / 266 (5.26%)	27 / 273 (9.89%)
occurrences all number	25	15	28
Tremor
subjects affected / exposed	13 / 273 (4.76%)	4 / 266 (1.50%)	21 / 273 (7.69%)
occurrences all number	14	4	23
General disorders and administration site conditions
Fatigue
subjects affected / exposed	18 / 273 (6.59%)	11 / 266 (4.14%)	27 / 273 (9.89%)
occurrences all number	21	12	28
Gastrointestinal disorders
Constipation
subjects affected / exposed	6 / 273 (2.20%)	5 / 266 (1.88%)	14 / 273 (5.13%)
occurrences all number	7	5	18
Diarrhoea
subjects affected / exposed	8 / 273 (2.93%)	14 / 266 (5.26%)	8 / 273 (2.93%)
occurrences all number	8	16	9
Dry mouth
subjects affected / exposed	14 / 273 (5.13%)	7 / 266 (2.63%)	10 / 273 (3.66%)
occurrences all number	14	7	10
Nausea
subjects affected / exposed	19 / 273 (6.96%)	13 / 266 (4.89%)	35 / 273 (12.82%)
occurrences all number	20	17	38
Psychiatric disorders
Insomnia
subjects affected / exposed	27 / 273 (9.89%)	17 / 266 (6.39%)	38 / 273 (13.92%)
occurrences all number	29	18	45
Restlessness
subjects affected / exposed	22 / 273 (8.06%)	7 / 266 (2.63%)	23 / 273 (8.42%)
occurrences all number	22	7	31
Metabolism and nutrition disorders
Increased appetite
subjects affected / exposed	5 / 273 (1.83%)	4 / 266 (1.50%)	14 / 273 (5.13%)
occurrences all number	5	4	14

More information

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Were there any global substantial amendments to the protocol? Yes

18 May 2012

• The Antidepressant Treatment History Form (ATHF) was added for documenting the identity, dose, duration, and response to qualifying ADT at screening • The eligibility criteria was modified in accordance with the ATHF, to expand the qualifying patient pool, and to allow conformance with local standards of care (specific changes included removing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) codes, increasing the allowed duration of the current episode to 24 months, adding fluoxetine to the allowed ADTs, removing the inclusion criterion based on SDS total score, adding an exclusion criterion for hospitalization, and expanding the allowed range of heart rate and BP measurements) • The sensitivity analysis, pattern-mixture model were modified to improve computational efficiency (change from mixed-effects model for repeated measures [MMRM] to analysis of covariance [ANCOVA])

11 Jul 2012

• Required washout period for fluoxetine was removed because fluoxetine was added to the allowed antidepressant treatments in Amendment 1 • The requirement for reflex collection of hemoglobin A1c was removed in subjects with elevated glucose because detectable changes occur over a duration of time that is longer than the study duration • Collection of folate and B12 to be based on the Investigator’s clinical judgment were modified • Azithromycin as a recommended macrolide antibiotic was removed

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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