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Clinical Trial Results:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

Summary
EudraCT number	2013-003038-34
Trial protocol	LT SK
Global end of trial date	16 Feb 2017

Results information
Results version number	v1(current)
This version publication date	03 May 2019
First version publication date	03 May 2019
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

D1002001

ISRCTN number

US NCT number

NCT01986101

WHO universal trial number (UTN)

Other trial identifiers

JapicCTI: 132318

Sponsor organisation name

Sumitomo Dainippon Pharma Co. Ltd.

Sponsor organisation address

1-13-1 Kyobashi, Chuo-ku, Tokyo, Japan, 104-8356

Public contact

Drug Development Division, Sumitomo Dainippon Pharmaceutical, cc@ds-pharma.co.jp

Scientific contact

Drug Development Division, Sumitomo Dainippon Pharmaceutical, cc@ds-pharma.co.jp

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

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

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

Analysis stage

Final

Date of interim/final analysis

25 Apr 2017

Is this the analysis of the primary completion data?

Yes

Primary completion date

01 Feb 2017

Global end of trial reached?

Yes

Global end of trial date

16 Feb 2017

Was the trial ended prematurely?

Main objective of the trial

The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients with Bipolar I Depression.

Protection of trial subjects

This study was conducted in accordance with the protocol, ICH GCP, local regulations and the ethical principles that had their origin in the Declaration of Helsinki. The study was conducted in accordance with applicable local law(s) and regulation(s).

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Feb 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Japan: 179

Country: Number of subjects enrolled

Malaysia: 19

Country: Number of subjects enrolled

Philippines: 11

Country: Number of subjects enrolled

Russian Federation: 145

Country: Number of subjects enrolled

Taiwan: 13

Country: Number of subjects enrolled

Ukraine: 132

Country: Number of subjects enrolled

Lithuania: 10

Country: Number of subjects enrolled

Slovakia: 16

Worldwide total number of subjects

525

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)

Adults (18-64 years)

507

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Subjects were to be evaluated for eligibility during a Screening period of 3-14 days, during which subjects were to be tapered off all psychotropic medications in a manner consistent with labeling recommendations and conventional medical practice.

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

once daily orally Placebo: Placebo comparator

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Placebo tablets were to be administered orally, once daily within 30 minutes after the evening meal.

SM-13496 20 - 60 mg/day

Arm description

once daily orally SM-13496: SM-13496 20mg for Days 1-7 and flexibly dosed at 20-60 mg/day for Weeks 2 to 6 (starting on Day 8)

Arm type

Experimental

Investigational medicinal product name

SM-13496

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

SM-13496 20, 40,or 60 mg/day, as 20 mg tablets, were administered orally once daily within 30 minutes after evening meal. SM-13496 dosing was to be fixed at 20 mg/day for Days 1 to 7 in the 20-60 mg/day treatment arm. SM-13496 was to be flexibly dosed for Weeks 2 to 6 (starting on Day 8).

SM-13496 80 - 120 mg/day

Arm description

once daily orally SM-13496: SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and flexibly dosed at 80-120 mg/day for Weeks 2 to 6 (starting on Day 8)

Arm type

Experimental

Investigational medicinal product name

SM-13496

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

SM-13496 20, 40, 60, 80, 100, or 120 mg/day, as 20 mg tablets, were administered orally once daily within 30 minutes after evening meal. Subjects randomized to the SM-13496 80-120 mg/day treatment arm were to receive SM-13496 20 mg/day on Days 1 and 2, 40 mg/day on Days 3 and 4, 60 mg/day on Days 5 and 6, and 80 mg/day on Day 7. SM-13496 was to be flexibly dosed for Weeks 2 to 6 (starting on Day 8).

Number of subjects in period 1	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Started	172	184	169
Intent-to-Treat Population	171	182	169
Safety Population	172	184	169
Completed	139	157	137
Not completed	33	27	32
Consent withdrawn by subject	14	13	5
Adverse event, non-fatal	7	6	16
Other reason	3	-	-
Lost to follow-up	1	1	-
Lack of efficacy	8	6	11
Noncompliance	-	1	-

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

once daily orally Placebo: Placebo comparator

Reporting group title

SM-13496 20 - 60 mg/day

Reporting group description

once daily orally SM-13496: SM-13496 20mg for Days 1-7 and flexibly dosed at 20-60 mg/day for Weeks 2 to 6 (starting on Day 8)

Reporting group title

SM-13496 80 - 120 mg/day

Reporting group description

Reporting group values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day	Total
Number of subjects	172	184	169	525
Age categorical
Units: Subjects
In utero	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0
Newborns (0-27 days)	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0
Children (2-11 years)	0	0	0	0
Adolescents (12-17 years)	0	0	0	0
Adults (18-64 years)	166	177	164	507
From 65-84 years	6	7	5	18
85 years and over	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	41.2 ± 12.63	42.7 ± 12.84	43.2 ± 12.78	-
Gender categorical
Units: Subjects
Female	95	96	88	279
Male	77	88	81	246
Race/Ethnicity, Customized
Units: Subjects
White	95	105	103	303
Asian	77	79	66	222
Region of Enrollment
Units: Subjects
Japan	60	66	53	179
Philippines	5	3	3	11
Taiwan	5	4	4	13
Ukraine	44	43	45	132
Malaysia	7	6	6	19
Slovakia	5	7	4	16
Lithuania	2	4	4	10
Russia	44	51	50	145
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Units: units on a scale
arithmetic mean (standard deviation)	30.9 ± 5.37	30.6 ± 5.55	30.8 ± 5.09	-
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Units: units on a scale
arithmetic mean (standard deviation)	4.60 ± 0.689	4.58 ± 0.705	4.58 ± 0.603	-

Subject analysis set title

Intention-to-treat population

Subject analysis set type

Intention-to-treat

Subject analysis set description

The ITT population consisted of all subjects who were randomized and took at least one dose of the study drug in the treatment phase, regardless of any protocol deviations, and who had baseline and at least one post-baseline evaluable MADRS total score.

Subject analysis sets values	Intention-to-treat population
Number of subjects	522
Age categorical
Units: Subjects
In utero
Preterm newborn infants (gestational age < 37 wks)
Newborns (0-27 days)
Infants and toddlers (28 days-23 months)
Children (2-11 years)
Adolescents (12-17 years)
Adults (18-64 years)
From 65-84 years
85 years and over
Age Continuous
Units: years
arithmetic mean (standard deviation)	42.4 ± 12.77
Gender categorical
Units: Subjects
Female	277
Male	245
Race/Ethnicity, Customized
Units: Subjects
White	302
Asian	220
Region of Enrollment
Units: Subjects
Japan	178
Philippines	11
Taiwan	12
Ukraine	131
Malaysia	19
Slovakia	16
Lithuania	10
Russia	145
Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
Units: units on a scale
arithmetic mean (standard deviation)	30.8 ± 5.35
Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) Score (Depression)
Units: units on a scale
arithmetic mean (standard deviation)	4.58 ± 0.666

End points

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Reporting group title

Placebo

Reporting group description

once daily orally Placebo: Placebo comparator

Reporting group title

SM-13496 20 - 60 mg/day

Reporting group description

once daily orally SM-13496: SM-13496 20mg for Days 1-7 and flexibly dosed at 20-60 mg/day for Weeks 2 to 6 (starting on Day 8)

Reporting group title

SM-13496 80 - 120 mg/day

Reporting group description

Subject analysis set title

Intention-to-treat population

Subject analysis set type

Intention-to-treat

Subject analysis set description

Primary: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

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End point title

Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

End point description

Montgomery-Asberg Depression Rating Scale (MADRS)is a clinician-rated assessment of a subject's level of depression. The MADRS total score ranges from a minimum of 0 to a maximum of 60. For the MADRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The MADRS contains ten (10) items. The total score is computed as the sum of the scores for the 10 items.

End point type

Primary

End point timeframe

Baseline to 6 weeks

End point values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Number of subjects analysed	171	182	169
Units: units on a scale
least squares mean (standard error)	-10.6 ± 0.72	-13.6 ± 0.69	-12.6 ± 0.73

Contrast (Placebo vs. SM-13496 20-60 mg/day)

Comparison groups

Placebo v SM-13496 20 - 60 mg/day

Number of subjects included in analysis

353

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[1]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2.9

Confidence interval

level

95%

sides

2-sided

lower limit

-4.9

upper limit

-1

Variability estimate

Standard error of the mean

Dispersion value

Notes
[1] - Hochberg-adjusted

Contrast (Placebo vs. SM-13496 80-120 mg/day)

Comparison groups

Placebo v SM-13496 80 - 120 mg/day

Number of subjects included in analysis

340

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.057 ^[2]

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-2

Confidence interval

level

95%

sides

2-sided

lower limit

-4

upper limit

0.1

Variability estimate

Standard error of the mean

Dispersion value

1.03

Notes
[2] - Hochberg-adjusted.

Secondary: Change from baseline in the CGI-BP-S (depression) score at Week 6

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End point title

Change from baseline in the CGI-BP-S (depression) score at Week 6

End point description

Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (depression) is a clinician-rated assessment of a subject's level of depression. The CGI depression score ranges from a minimum of 1 to a maximum of 7. For the CGI depression score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome.

End point type

Secondary

End point timeframe

Baseline to 6 weeks

End point values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Number of subjects analysed	171	182	169
Units: units on a scale
least squares mean (standard error)	-1.11 ± 0.092	-1.51 ± 0.088	-1.41 ± 0.093

Contrast (Placebo vs. SM-13496 80-120 mg/day)

Comparison groups

Placebo v SM-13496 80 - 120 mg/day

Number of subjects included in analysis

340

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.31

Confidence interval

level

95%

sides

2-sided

lower limit

-0.56

upper limit

-0.05

Variability estimate

Standard error of the mean

Dispersion value

0.13

Contrast (Placebo vs. SM-13496 20-60 mg/day)

Comparison groups

Placebo v SM-13496 20 - 60 mg/day

Number of subjects included in analysis

353

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.65

upper limit

-0.15

Variability estimate

Standard error of the mean

Dispersion value

0.127

Secondary: Change from baseline in the SDS total score at Week 6(LOCF)

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End point title

Change from baseline in the SDS total score at Week 6(LOCF)

End point description

Sheehan Disability Scale (SDS) total score is a subject-rated assessment of a subject's level of depression. The SDS total score ranges from a minimum of 0 to a maximum of 30. For the SDS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The SDS contains three (3) items. The total score is computed as the sum of the scores for the 3 items.

End point type

Secondary

End point timeframe

Baseline to 6 weeks

End point values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Number of subjects analysed	128	147	124
Units: units on a scale
least squares mean (standard error)	-5.7 ± 0.66	-7.6 ± 0.62	-6.8 ± 0.67

Contrast (Placebo vs. SM-13496 20-60 mg/day)

Comparison groups

Placebo v SM-13496 20 - 60 mg/day

Number of subjects included in analysis

275

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.037

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-1.8

Confidence interval

level

95%

sides

2-sided

lower limit

-3.6

upper limit

-0.1

Variability estimate

Standard error of the mean

Dispersion value

0.89

Contrast (Placebo vs. SM-13496 80-120 mg/day)

Comparison groups

Placebo v SM-13496 80 - 120 mg/day

Number of subjects included in analysis

252

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.223

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-1.1

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

0.7

Variability estimate

Standard error of the mean

Dispersion value

0.92

Secondary: Change from baseline in the YMRS total score at Week 6(LOCF)

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End point title

Change from baseline in the YMRS total score at Week 6(LOCF)

End point description

YMRS (Young Mania Rating Scale) is a clinician-rated assessment of the severity of mania in subjects with a diagnosis of bipolar disorder. The YMRS total score ranges from a minimum of 0 to a maximum of 60. For the YMRS total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The YMRS contains eleven (11) items. The total score is computed as the sum of the scores for the 11 items.

End point type

Secondary

End point timeframe

Baseline to 6 weeks

End point values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Number of subjects analysed	171	182	169
Units: units on a scale
least squares mean (standard error)	-0.51 ± 0.190	-0.98 ± 0.180	-0.99 ± 0.191

Contrast (Placebo vs. SM-13496 20-60 mg/day)

Comparison groups

Placebo v SM-13496 20 - 60 mg/day

Number of subjects included in analysis

353

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.076

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.47

Confidence interval

level

95%

sides

2-sided

lower limit

-0.98

upper limit

0.05

Variability estimate

Standard error of the mean

Dispersion value

0.262

Contrast (Placebo vs. SM-13496 80-120 mg/day)

Comparison groups

Placebo v SM-13496 80 - 120 mg/day

Number of subjects included in analysis

340

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.075

Method

Mixed models analysis

Parameter type

Mean difference (final values)

Point estimate

-0.48

Confidence interval

level

95%

sides

2-sided

lower limit

-1.01

upper limit

0.05

Variability estimate

Standard error of the mean

Dispersion value

0.269

Secondary: Change from baseline in the HAM-A total score at Week 6(LOCF)

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End point title

Change from baseline in the HAM-A total score at Week 6(LOCF)

End point description

The Hamilton Rating Scale for Anxiety (HAM-A) scale is a rating scale developed to quantify the severity of anxiety symptomatology. The HAM-A total score ranges from a minimum of 0 to a maximum of 56. For the HAM-A total score, low scores indicate a better outcome and high scores indicate a worse outcome. When change from baseline is considered, a negative (decrease in score) value is considered a better outcome, and a positive (increase in score) value is considered a worse outcome. The HAM-A contains fourteen (14) items. The total score is computed as the sum of the scores for the 14 items.

End point type

Secondary

End point timeframe

Baseline to 6 weeks

End point values	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Number of subjects analysed	164	179	167
Units: units on a scale
least squares mean (standard error)	-5.7 ± 0.51	-7.4 ± 0.49	-6.4 ± 0.50

Contrast (Placebo vs. SM-13496 20-60 mg/day)

Comparison groups

Placebo v SM-13496 20 - 60 mg/day

Number of subjects included in analysis

343

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-1.7

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

-0.3

Variability estimate

Standard error of the mean

Dispersion value

0.7

Contrast (Placebo vs. SM-13496 80-120 mg/day)

Comparison groups

Placebo v SM-13496 80 - 120 mg/day

Number of subjects included in analysis

331

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.294

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-2.1

upper limit

0.7

Variability estimate

Standard error of the mean

Dispersion value

0.71

Adverse events

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Timeframe for reporting adverse events

6 weeks

Adverse event reporting additional description

Safety population is analyzed.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.1

Reporting group title

Placebo

Reporting group description

once daily orally Placebo

Reporting group title

SM-13496 20 - 60 mg/day

Reporting group description

once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day

Reporting group title

SM-13496 80 - 120 mg/day

Reporting group description

once daily orally SM-13496 (lurasidone HCl): SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day

Serious adverse events	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 172 (2.91%)	2 / 184 (1.09%)	4 / 169 (2.37%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events	0	0	0
Injury, poisoning and procedural complications
Tendon rupture
subjects affected / exposed	0 / 172 (0.00%)	0 / 184 (0.00%)	1 / 169 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 172 (0.58%)	0 / 184 (0.00%)	0 / 169 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Disease progression
subjects affected / exposed	1 / 172 (0.58%)	0 / 184 (0.00%)	1 / 169 (0.59%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 172 (0.58%)	0 / 184 (0.00%)	0 / 169 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Bipolar I disorder
subjects affected / exposed	1 / 172 (0.58%)	0 / 184 (0.00%)	0 / 169 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mania
subjects affected / exposed	1 / 172 (0.58%)	1 / 184 (0.54%)	0 / 169 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Panic attack
subjects affected / exposed	0 / 172 (0.00%)	0 / 184 (0.00%)	1 / 169 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Suicidal ideation
subjects affected / exposed	0 / 172 (0.00%)	1 / 184 (0.54%)	0 / 169 (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
Suicide attempt
subjects affected / exposed	0 / 172 (0.00%)	0 / 184 (0.00%)	1 / 169 (0.59%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
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	Placebo	SM-13496 20 - 60 mg/day	SM-13496 80 - 120 mg/day
Total subjects affected by non serious adverse events
subjects affected / exposed	44 / 172 (25.58%)	49 / 184 (26.63%)	75 / 169 (44.38%)
Nervous system disorders
Akathisia
subjects affected / exposed	11 / 172 (6.40%)	24 / 184 (13.04%)	40 / 169 (23.67%)
occurrences all number	12	27	46
Headache
subjects affected / exposed	15 / 172 (8.72%)	5 / 184 (2.72%)	9 / 169 (5.33%)
occurrences all number	22	7	11
Parkinsonism
subjects affected / exposed	4 / 172 (2.33%)	4 / 184 (2.17%)	10 / 169 (5.92%)
occurrences all number	7	4	19
Somnolence
subjects affected / exposed	7 / 172 (4.07%)	7 / 184 (3.80%)	11 / 169 (6.51%)
occurrences all number	8	7	12
Gastrointestinal disorders
Nausea
subjects affected / exposed	10 / 172 (5.81%)	12 / 184 (6.52%)	20 / 169 (11.83%)
occurrences all number	13	13	23
Infections and infestations
Nasopharyngitis
subjects affected / exposed	8 / 172 (4.65%)	10 / 184 (5.43%)	6 / 169 (3.55%)
occurrences all number	8	10	6

More information

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Were there any global substantial amendments to the protocol? No

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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Clinical trials

Clinical Trial Results:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

Primary: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

Secondary: Change from baseline in the CGI-BP-S (depression) score at Week 6

Secondary: Change from baseline in the CGI-BP-S (depression) score at Week 6

Secondary: Change from baseline in the SDS total score at Week 6(LOCF)

Secondary: Change from baseline in the SDS total score at Week 6(LOCF)

Secondary: Change from baseline in the YMRS total score at Week 6(LOCF)

Secondary: Change from baseline in the YMRS total score at Week 6(LOCF)

Secondary: Change from baseline in the HAM-A total score at Week 6(LOCF)

Secondary: Change from baseline in the HAM-A total score at Week 6(LOCF)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

Primary: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at Week 6

Secondary: Change from baseline in the CGI-BP-S (depression) score at Week 6

Secondary: Change from baseline in the CGI-BP-S (depression) score at Week 6

Secondary: Change from baseline in the SDS total score at Week 6(LOCF)

Secondary: Change from baseline in the SDS total score at Week 6(LOCF)

Secondary: Change from baseline in the YMRS total score at Week 6(LOCF)

Secondary: Change from baseline in the YMRS total score at Week 6(LOCF)

Secondary: Change from baseline in the HAM-A total score at Week 6(LOCF)

Secondary: Change from baseline in the HAM-A total score at Week 6(LOCF)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of SM-13496 for the Treatment of Bipolar I Depression.