Back to resultsSafety and Efficacy of Cariprazine for Bipolar I Disorder
Primary Purpose
Mania, Bipolar I Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cariprazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Mania focused on measuring Acute Mania, Bipolar I Disorder
Eligibility Criteria
Inclusion Criteria:
- Patients who have provided informed consent prior to any study specific procedures
- Patients 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 for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
- Voluntarily hospitalized for current manic episode
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
Exclusion Criteria:
- Patients 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 six months
Sites / Locations
- Forest Investigative Site 018
- Forest Investigative Site 012
- Forest Investigative Site 010
- Forest Investigative Site 005
- Forest Investigative Site 023
- Forest Investigative Site 017
- Forest Investigative Site 024
- Forest Investigative Site 016
- Forest Investigative Site 007
- Forest Investigative Site 002
- Forest Investigative Site 003
- Forest Investigative Site 026
- Forest Investigative Site 013
- Forest Investigative Site 011
- Forest Investigative Site 021
- Forest Investigative Site 001
- Forest Investigative Site 006
- Forest Investigative Site 025
- Forest Investigative Site 008
- Forest Investigative Site 019
- Forest Investigative Site 015
- Forest Investigative Site 004
- Forest Investigative Site 014
- Forest Investigative Site 607
- Forest Investigative Site 602
- Forest Investigative Site 605
- Forest Investigative Site 606
- Forest Investigative Site 204
- Forest Investigative Site 210
- Forest Investigative Site 211
- Forest Investigative Site 212
- Forest Investigative Site 209
- Forest Investigative Site 203
- Forest Investigative Site 205
- Forest Investigative Site 206
- Forest Investigative Site 208
- Forest Investigative Site 202
- Forest Investigative Site 201
- Forest Investigative Site 501
- Forest Investigative Site 503
- Forest Investigative Site 507
- Forest Investigative Site 510
- Forest Investigative Site 506
- Forest Investigative Site 508
- Forest Investigative Site 509
- Forest Investigative Site 504
- Forest Investigative Site 502
- Forest Investigative Site 403
- Forest Investigative Site 404
- Forest Investigative Site 405
- Forest Investigative Site 402
- Forest Investigative Site 401
- Forest Investigative Site 308
- Forest Investigative Site 315
- Forest Investigative Site 301
- Forest Investigative Site 307
- Forest Investigative Site 310
- Forest Investigative Site 304
- Forest Investigative Site 305
- Forest Investigative Site 303
- Forest Investigative Site 309
- Forest Investigative Site 312
- Forest Investigative Site 306
- Forest Investigative Site 311
- Forest Investigative Site 302
- Forest Investigative Site 314
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cariprazine (3-6 mg/day)
Cariprazine (6-12 mg/day)
Placebo
Arm Description
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Secondary Outcome Measures
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Full Information
NCT ID
NCT01058668
First Posted
January 27, 2010
Last Updated
March 1, 2017
Sponsor
Forest Laboratories
Collaborators
Gedeon Richter Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01058668
Brief Title
Safety and Efficacy of Cariprazine for Bipolar I Disorder
Official Title
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (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 is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mania, Bipolar I Disorder
Keywords
Acute Mania, Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
497 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cariprazine (3-6 mg/day)
Arm Type
Experimental
Arm Description
Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
Arm Title
Cariprazine (6-12 mg/day)
Arm Type
Experimental
Arm Description
Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Cariprazine
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for three weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for three weeks.
Primary Outcome Measure Information:
Title
Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3
Description
The YMRS is an 11-item scale that assesses manic symptoms based on the participant's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11-items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of the abnormality for 7-items are rated on a five-point scale (0-4) and 4-items on a nine-point scale (0-8). The individual scores are summed for a total possible score of 0 (best) to 60 (worst). A negative change from Baseline indicates improvement. Analysis is a mixed model for repeated measurements (MMRM) using observed cases, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time Frame
Baseline, Week 3
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3
Description
The CGI-S measures the investigator's assessment of overall severity of the participant's illness compared with the severity of illness in other patients the physician has observed using a 7-point scale (1=Normal, not ill at all to 7= Among the most extremely ill participants). A negative change from Baseline indicates improvement. Analysis is based on a MMRM using the observed cases data, with treatment group, pooled study center, visit, treatment group-by-visit interaction as factors, baseline value and baseline-by-visit interaction as covariates and an unstructured covariance matrix.
Time Frame
Baseline, Week 3
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:
Patients who have provided informed consent prior to any study specific procedures
Patients 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 for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID) manic or mixed type with or without psychotic symptoms
Voluntarily hospitalized for current manic episode
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
Exclusion Criteria:
Patients 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 six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Diaz, MD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 018
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Forest Investigative Site 012
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
Forest Investigative Site 010
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Forest Investigative Site 005
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Forest Investigative Site 023
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Forest Investigative Site 017
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Forest Investigative Site 024
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Forest Investigative Site 016
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Forest Investigative Site 007
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Forest Investigative Site 002
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 003
City
Orlando
State/Province
Florida
ZIP/Postal Code
32821
Country
United States
Facility Name
Forest Investigative Site 026
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Forest Investigative Site 013
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Forest Investigative Site 011
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Forest Investigative Site 021
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Forest Investigative Site 001
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71115
Country
United States
Facility Name
Forest Investigative Site 006
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Forest Investigative Site 025
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
Forest Investigative Site 008
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Forest Investigative Site 019
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Forest Investigative Site 015
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Forest Investigative Site 004
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States
Facility Name
Forest Investigative Site 014
City
Bothell
State/Province
Washington
ZIP/Postal Code
98011
Country
United States
Facility Name
Forest Investigative Site 607
City
Rijeka
ZIP/Postal Code
51 000
Country
Croatia
Facility Name
Forest Investigative Site 602
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Forest Investigative Site 605
City
Zagreb
ZIP/Postal Code
10 000
Country
Croatia
Facility Name
Forest Investigative Site 606
City
Zagreb
ZIP/Postal Code
10 090
Country
Croatia
Facility Name
Forest Investigative Site 204
City
Targoviste
State/Province
Dambovita
ZIP/Postal Code
130086
Country
Romania
Facility Name
Forest Investigative Site 210
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200745
Country
Romania
Facility Name
Forest Investigative Site 211
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300182
Country
Romania
Facility Name
Forest Investigative Site 212
City
Focsani
State/Province
Vrancea
ZIP/Postal Code
620165
Country
Romania
Facility Name
Forest Investigative Site 209
City
Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Forest Investigative Site 203
City
Bucharest
ZIP/Postal Code
041915
Country
Romania
Facility Name
Forest Investigative Site 205
City
Bucuresti
ZIP/Postal Code
041915
Country
Romania
Facility Name
Forest Investigative Site 206
City
Bucuresti
ZIP/Postal Code
041915
Country
Romania
Facility Name
Forest Investigative Site 208
City
Bucuresti
ZIP/Postal Code
041915
Country
Romania
Facility Name
Forest Investigative Site 202
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Facility Name
Forest Investigative Site 201
City
Craiova
ZIP/Postal Code
200260
Country
Romania
Facility Name
Forest Investigative Site 501
City
Lipetsk
ZIP/Postal Code
398007
Country
Russian Federation
Facility Name
Forest Investigative Site 503
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site 507
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site 510
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Forest Investigative Site 506
City
Saint Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Facility Name
Forest Investigative Site 508
City
Saint Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Forest Investigative Site 509
City
Samara
ZIP/Postal Code
443016
Country
Russian Federation
Facility Name
Forest Investigative Site 504
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Forest Investigative Site 502
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Forest Investigative Site 403
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 404
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 405
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Forest Investigative Site 402
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Forest Investigative Site 401
City
Senta
ZIP/Postal Code
24400
Country
Serbia
Facility Name
Forest Investigative Site 308
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Forest Investigative Site 315
City
Dnipropetrovsk
ZIP/Postal Code
49115
Country
Ukraine
Facility Name
Forest Investigative Site 301
City
Donetsk
ZIP/Postal Code
83008
Country
Ukraine
Facility Name
Forest Investigative Site 307
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 310
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Forest Investigative Site 304
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Forest Investigative Site 305
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Facility Name
Forest Investigative Site 303
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 309
City
Kyiv
ZIP/Postal Code
04080
Country
Ukraine
Facility Name
Forest Investigative Site 312
City
Kyiv
ZIP/Postal Code
08631
Country
Ukraine
Facility Name
Forest Investigative Site 306
City
Lugansk
ZIP/Postal Code
91045
Country
Ukraine
Facility Name
Forest Investigative Site 311
City
Lviv
ZIP/Postal Code
79021
Country
Ukraine
Facility Name
Forest Investigative Site 302
City
Odessa
ZIP/Postal Code
65006
Country
Ukraine
Facility Name
Forest Investigative Site 314
City
Poltava
ZIP/Postal Code
36006
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
31344528
Citation
McIntyre RS, Masand PS, Earley W, Patel M. Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials. J Affect Disord. 2019 Oct 1;257:600-606. doi: 10.1016/j.jad.2019.07.020. Epub 2019 Jul 5.
Results Reference
derived
PubMed Identifier
29017067
Citation
Earley W, Durgam S, Lu K, Ruth A, Nemeth G, Laszlovszky I, Yatham LN. Clinically relevant response and remission outcomes in cariprazine-treated patients with bipolar I disorder. J Affect Disord. 2018 Jan 15;226:239-244. doi: 10.1016/j.jad.2017.09.040. Epub 2017 Sep 25.
Results Reference
derived
PubMed Identifier
25562205
Citation
Calabrese JR, Keck PE Jr, Starace A, Lu K, Ruth A, Laszlovszky I, Nemeth G, Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J Clin Psychiatry. 2015 Mar;76(3):284-92. doi: 10.4088/JCP.14m09081.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Cariprazine for Bipolar I Disorder
We'll reach out to this number within 24 hrs