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Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

Primary Purpose

Depression, Bipolar

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
Cariprazine
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression, Bipolar focused on measuring Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who have provided informed consent prior to any study specific procedures.
  • Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
  • Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
  • Verified previous manic or mixed episode.
  • Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
  • Participants with a HAMD-17 item 1 score ≥ 2.
  • Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

  • Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
  • Women who are pregnant or breast feeding
  • Participants with Young Mania Rating Scale (YMRS) total score > 10
  • Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.

Sites / Locations

  • Forest Investigative Site 021
  • Forest Investigative Site 017
  • Forest Investigative Site 030
  • Forest Investigative Site 018
  • Forest Investigative Site 028
  • Forest Investigative Site 015
  • Forest Investigative Site 011
  • Forest Investigative Site 012
  • Forest Investigative Site 035
  • Forest Investigative Site 013
  • Forest Investigative Site 038
  • Forest Investigative Site 005
  • Forest Investigative Site 029
  • Forest Investigative Site 024
  • Forest Investigative Site 031
  • Forest Investigative Site 041
  • Forest Investigative Site 040
  • Forest Investigative Site 039
  • Forest Investigative Site 026
  • Forest Investigative Site 037
  • Forest Investigative Site 023
  • Forest Investigative Site 014
  • Forest Investigative Site 006
  • Forest Investigative Site 003
  • Forest Investigative Site 025
  • Forest Investigative Site 036
  • Forest Investigative Site 008
  • Forest Investigative Site 042
  • Forest Investigative Site 009
  • Forest Investigative Site 010
  • Forest Investigative Site 033
  • Forest Investigative Site 019
  • Forest Investigative Site 007
  • Forest Investigative Site 016
  • Forest Investigative Site 027
  • Forest Investigative Site 020
  • Forest Investigative Site 043
  • Forest Investigative Site 032
  • Forest Investigative Site 311
  • Forest Investigative Site 307
  • Forest Investigative Site 310
  • Forest Investigative Site 313
  • Forest Investigative Site 309
  • Forest Investigative Site 302
  • Forest Investigative Site 301
  • Forest Investigative Site 305
  • Forest Investigative Site 306
  • Forest Investigative Site 308
  • Forest Investigative Site 312
  • Forest Investigative Site 102
  • Forest Investigative Site 103
  • Forest Investigative Site 101
  • Forest Investigative Site 804
  • Forest Investigative Site 806
  • Forest Investigative Site 803
  • Forest Investigative Site 805
  • Forest Investigative Site 808
  • Forest Investigative Site 807
  • Forest Investigative Site 601
  • Forest Investigative Site 605
  • Forest Investigative Site 607
  • Forest Investigative Site 611
  • Forest Investigative Site 619
  • Forest Investigative Site 603
  • Forest Investigative Site 612
  • Forest Investigative Site 617
  • Forest Investigative Site 616
  • Forest Investigative Site 604
  • Forest Investigative Site 606
  • Forest Investigative Site 602
  • Forest Investigative Site 613
  • Forest Investigative Site 608
  • Forest Investigative Site 615
  • Forest Investigative Site 609
  • Forest Investigative Site 618
  • Forest Investigative Site 610
  • Forest Investigative Site 707
  • Forest Investigative Site 709
  • Forest Investigative Site 714
  • Forest Investigative Site 712
  • Forest Investigative Site 703
  • Forest Investigative Site 704
  • Forest Investigative Site 702
  • Forest Investigative Site 708
  • Forest Investigative Site 701
  • Forest Investigative Site 710
  • Forest Investigative Site 706
  • Forest Investigative Site 705

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Cariprazine 0.75 mg

Cariprazine 1.5 mg

Cariprazine 3.0 mg

Arm Description

Participants received placebo orally once a day for 8 weeks.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2011
Last Updated
March 29, 2018
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01396447
Brief Title
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Official Title
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 26, 2011 (Actual)
Primary Completion Date
January 10, 2014 (Actual)
Study Completion Date
January 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of participants with bipolar depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Bipolar
Keywords
Bipolar I disorder, Bipolar depression, Depression, Bipolar disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo orally once a day for 8 weeks.
Arm Title
Cariprazine 0.75 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Cariprazine 1.5 mg
Arm Type
Experimental
Arm Description
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 Title
Cariprazine 3.0 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo was supplied in capsules.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Cariprazine was supplied in capsules.
Primary Outcome Measure Information:
Title
Change From Baseline in the Montgomery-Åsberg Depression Rating Scale Total Score at Week 6
Description
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.
Time Frame
Baseline to Week 6
Secondary Outcome Measure Information:
Title
Change From Baseline in the Clinical Global Impressions-Severity Total Score at Week 6
Description
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.
Time Frame
Baseline to Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who have provided informed consent prior to any study specific procedures. Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration. Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG). Verified previous manic or mixed episode. Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20. Participants with a HAMD-17 item 1 score ≥ 2. Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4. Exclusion Criteria: Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months. Women who are pregnant or breast feeding Participants with Young Mania Rating Scale (YMRS) total score > 10 Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willie Earley, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 021
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Forest Investigative Site 017
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Forest Investigative Site 030
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Forest Investigative Site 018
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 028
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 015
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 011
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Forest Investigative Site 012
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Forest Investigative Site 035
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 013
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Forest Investigative Site 038
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 005
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Forest Investigative Site 029
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Forest Investigative Site 024
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Forest Investigative Site 031
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Forest Investigative Site 041
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70629
Country
United States
Facility Name
Forest Investigative Site 040
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Forest Investigative Site 039
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Forest Investigative Site 026
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Forest Investigative Site 037
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Forest Investigative Site 023
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Forest Investigative Site 014
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Forest Investigative Site 006
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Forest Investigative Site 003
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 025
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forest Investigative Site 036
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Forest Investigative Site 008
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Forest Investigative Site 042
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Forest Investigative Site 009
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Forest Investigative Site 010
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Forest Investigative Site 033
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Forest Investigative Site 019
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 007
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Forest Investigative Site 016
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Forest Investigative Site 027
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Forest Investigative Site 020
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 043
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Forest Investigative Site 032
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Forest Investigative Site 311
City
Kardzhali
ZIP/Postal Code
6600
Country
Bulgaria
Facility Name
Forest Investigative Site 307
City
Kazanlak
ZIP/Postal Code
6100
Country
Bulgaria
Facility Name
Forest Investigative Site 310
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Facility Name
Forest Investigative Site 313
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Facility Name
Forest Investigative Site 309
City
Pazardzhik
ZIP/Postal Code
4400
Country
Bulgaria
Facility Name
Forest Investigative Site 302
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Forest Investigative Site 301
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Forest Investigative Site 305
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Forest Investigative Site 306
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Forest Investigative Site 308
City
Tsarev Brod
ZIP/Postal Code
9747
Country
Bulgaria
Facility Name
Forest Investigative Site 312
City
Tserova Koria
ZIP/Postal Code
5047
Country
Bulgaria
Facility Name
Forest Investigative Site 102
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Forest Investigative Site 103
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Forest Investigative Site 101
City
Chatham
State/Province
Ontario
ZIP/Postal Code
N7L 5L9
Country
Canada
Facility Name
Forest Investigative Site 804
City
Barranquilla
Country
Colombia
Facility Name
Forest Investigative Site 806
City
Barranquilla
Country
Colombia
Facility Name
Forest Investigative Site 803
City
Bogota
Country
Colombia
Facility Name
Forest Investigative Site 805
City
Bogotá
Country
Colombia
Facility Name
Forest Investigative Site 808
City
Bogotá
Country
Colombia
Facility Name
Forest Investigative Site 807
City
Pereira
Country
Colombia
Facility Name
Forest Investigative Site 601
City
Arkhangelsk
ZIP/Postal Code
163530
Country
Russian Federation
Facility Name
Forest Investigative Site 605
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Forest Investigative Site 607
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site 611
City
Moscow
ZIP/Postal Code
117152
Country
Russian Federation
Facility Name
Forest Investigative Site 619
City
Moscow
ZIP/Postal Code
127083
Country
Russian Federation
Facility Name
Forest Investigative Site 603
City
Nizhniy Novgorod
ZIP/Postal Code
603152
Country
Russian Federation
Facility Name
Forest Investigative Site 612
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Forest Investigative Site 617
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Forest Investigative Site 616
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Forest Investigative Site 604
City
St. Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Forest Investigative Site 606
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Forest Investigative Site 602
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Forest Investigative Site 613
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Forest Investigative Site 608
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Forest Investigative Site 615
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Facility Name
Forest Investigative Site 609
City
Tomsk
ZIP/Postal Code
634014
Country
Russian Federation
Facility Name
Forest Investigative Site 618
City
Tver
ZIP/Postal Code
170005
Country
Russian Federation
Facility Name
Forest Investigative Site 610
City
Voronezh
ZIP/Postal Code
394052
Country
Russian Federation
Facility Name
Forest Investigative Site 707
City
Kerch
State/Province
AR Crimea
ZIP/Postal Code
98310
Country
Ukraine
Facility Name
Forest Investigative Site 709
City
Kherson
State/Province
Vil. Stepanivka
ZIP/Postal Code
73488
Country
Ukraine
Facility Name
Forest Investigative Site 714
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Forest Investigative Site 712
City
Ivano-Frankivsk
ZIP/Postal Code
76014
Country
Ukraine
Facility Name
Forest Investigative Site 703
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 704
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 702
City
Kharkiv
ZIP/Postal Code
61103
Country
Ukraine
Facility Name
Forest Investigative Site 708
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Forest Investigative Site 701
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 710
City
Odesa
ZIP/Postal Code
65014
Country
Ukraine
Facility Name
Forest Investigative Site 706
City
Simferopol
ZIP/Postal Code
95006
Country
Ukraine
Facility Name
Forest Investigative Site 705
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
34034612
Citation
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 Reference
derived
PubMed Identifier
33915374
Citation
Citrome L, Yatham LN, Patel MD, Barabassy A, Hankinson A, Earley WR. Cariprazine and akathisia, restlessness, and extrapyramidal symptoms in patients with bipolar depression. J Affect Disord. 2021 Jun 1;288:191-198. doi: 10.1016/j.jad.2021.03.076. Epub 2021 Mar 31.
Results Reference
derived
PubMed Identifier
33677183
Citation
Thase ME, Harrington A, Calabrese J, Montgomery S, Niu X, Patel MD. Evaluation of MADRS severity thresholds in patients with bipolar depression. J Affect Disord. 2021 May 1;286:58-63. doi: 10.1016/j.jad.2021.02.043. Epub 2021 Feb 20.
Results Reference
derived
PubMed Identifier
32942346
Citation
Yatham LN, Vieta E, McIntyre RS, Jain R, Patel M, Earley W. Broad Efficacy of Cariprazine on Depressive Symptoms in Bipolar Disorder and the Clinical Implications. Prim Care Companion CNS Disord. 2020 Sep 17;22(5):20m02611. doi: 10.4088/PCC.20m02611.
Results Reference
derived
PubMed Identifier
31969269
Citation
Earley WR, Burgess M, Rekeda L, Hankinson A, McIntyre RS, Suppes T, Calabrese JR, Yatham LN. A pooled post hoc analysis evaluating the safety and tolerability of cariprazine in bipolar depression. J Affect Disord. 2020 Feb 15;263:386-395. doi: 10.1016/j.jad.2019.11.098. Epub 2019 Nov 22.
Results Reference
derived
PubMed Identifier
26541814
Citation
Durgam S, Earley W, Lipschitz A, Guo H, Laszlovszky I, Nemeth G, Vieta E, Calabrese JR, Yatham LN. An 8-Week Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in Patients With Bipolar I Depression. Am J Psychiatry. 2016 Mar 1;173(3):271-81. doi: 10.1176/appi.ajp.2015.15020164. Epub 2015 Nov 6.
Results Reference
derived

Learn more about this trial

Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression

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