Safety, Tolerability, and Efficacy of Cariprazine in Part... | NCT01396447

ID	Type	Description	Link
2011-002334-39	EudraCT Number

Status Module

Name	Class
Gedeon Richter Ltd.	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Participants received placebo orally once a day for 8 weeks.	Drug: Placebo
Cariprazine 0.75 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	Drug: Cariprazine
Cariprazine 1.5 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	Drug: Cariprazine
Cariprazine 3.0 mg	Experimental	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.	Drug: Cariprazine

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo was supplied in capsules.	Placebo
Cariprazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6	The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.	Baseline to Week 6

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6	The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.

Eligibility Module

Name	Affiliation	Role
Willie Earley, MD	Allergan	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Forest Investigative Site 021		Birmingham	Alabama	35216	United States
Forest Investigative Site 017

PubMed Identifier	Type	Citation	Retractions
39520655	Derived	McIntyre RS, Llorca PM, Aronin LC, Yu J, Nguyen HB. Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials. Adv Ther. 2025 Jan;42(1):246-260. doi: 10.1007/s12325-024-03009-2. Epub 2024 Nov 9.
34034612	Derived	Vieta E, Calabrese JR, Whelan J, Tohen M, Earley WR. The efficacy of cariprazine on function in patients with bipolar depression: a post hoc analysis of a randomized controlled trial. Curr Med Res Opin. 2021 Sep;37(9):1635-1643. doi: 10.1080/03007995.2021.1932446. Epub 2021 Jun 7.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received placebo orally once a day for 8 weeks.
FG001	Cariprazine 0.75 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received placebo orally once a day for 8 weeks.
BG001	Cariprazine 0.75 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
BG002	Cariprazine 1.5 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
BG003	Cariprazine 3.0 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.6± 12.0 BG00140.1± 11.2 BG00240.9± 11.4 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00089 BG00191 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00012 BG00113 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
White	BG000110 BG001111 BG002

Weight

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00079.98± 17.08 BG00180.81± 18.36 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.81± 5.27 BG00128.42± 5.71 BG002

Waist circumference

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00091.40± 14.24 BG00193.32± 15.45 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6

The Montgomery-Åsberg Depression Rating Scale is a 10-item, clinician-rated scale that evaluates the participant's depressive symptomatology during the past week. Participants are rated on items assessing feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity. The scores on the 10 items are summed for a total score that can range from 0 to 60. A higher score indicates greater depression. A negative change score indicates improvement.

Intent-to-treat population: All randomized participants who took at least 1 dose of investigational product and had at least 1 post-Baseline assessment of the Montgomery-Åsberg Depression Rating Scale.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo orally once a day for 8 weeks.
OG001	Cariprazine 0.75 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
OG002	Cariprazine 1.5 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.
OG003	Cariprazine 3.0 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.

Units	Counts
Participants	OG000141 OG001140 OG002145 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-11.1± 0.9 OG001-13.0± 0.9 OG002-15.1± 0.8 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Repeated measures mixed-effects model		0.1292	The analysis included 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.	Mean Difference (Final Values)	-1.9			2-Sided	95	-4.3	0.5			Cariprazine 0.75 mg vs Placebo		Superiority

Secondary

Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6

The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 6

ID	Title	Description
OG000	Placebo	Participants received placebo orally once a day for 8 weeks.
OG001	Cariprazine 0.75 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.
OG002	Cariprazine 1.5 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received placebo orally once a day for 8 weeks.	145	5	145	42	145
EG001	Cariprazine 0.75 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2 and cariprazine 0.75 mg orally once a day starting on Day 3 for the remainder of the 8 week treatment period.	141	1	141	43	141
EG002	Cariprazine 1.5 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, and cariprazine 1.5 mg orally once a day starting on Day 8 for the remainder of the 8 week treatment period.	146	2	146	51	146
EG003	Cariprazine 3.0 mg	Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.	146	2	146	56	146

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected145 at risk EG0010 affected141 at risk EG0021 affected146 at risk EG0031 affected146 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA, Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA, Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0010 affected141 at risk EG0021 affected146 at risk EG003
Vertigo CNS origin	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA, Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003
Depression	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0011 affected141 at risk EG0020 affected146 at risk EG003
Hypomania	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG0000 affected145 at risk EG0010 affected141 at risk EG0021 affected146 at risk EG003
Mania	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA, Version 16.1	Systematic Assessment	EG0001 affected145 at risk EG0010 affected141 at risk EG0020 affected146 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0007 affected145 at risk EG00112 affected141 at risk EG00212 affected146 at risk EG00312 affected146 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA, Version 16.1	Systematic Assessment	EG00010 affected145 at risk EG0012 affected141 at risk EG0029 affected146 at risk EG003
Akathisia	Nervous system disorders	MedDRA, Version 16.1	Systematic Assessment	EG0002 affected145 at risk EG0014 affected141 at risk EG0027 affected146 at risk EG003
Headache	Nervous system disorders	MedDRA, Version 16.1	Systematic Assessment	EG00017 affected145 at risk EG00111 affected141 at risk EG00211 affected146 at risk EG003
Somnolence	Nervous system disorders	MedDRA, Version 16.1	Systematic Assessment	EG0007 affected145 at risk EG0016 affected141 at risk EG00210 affected146 at risk EG003
Insomnia	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG00012 affected145 at risk EG00116 affected141 at risk EG00210 affected146 at risk EG003
Restlessness	Psychiatric disorders	MedDRA, Version 16.1	Systematic Assessment	EG0005 affected145 at risk EG0014 affected141 at risk EG0024 affected146 at risk EG003

ID	Term
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior