Safety and Efficacy of Cariprazine for Bipolar I Disorder
- Registration Number
- NCT01058668
- Lead Sponsor
- Forest Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 497
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cariprazine (6-12 mg/day) Cariprazine Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks. Placebo Placebo Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. Cariprazine (3-6 mg/day) Cariprazine Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in the Young Mania Rating Scale (YMRS) Total Score at Week 3 Baseline, 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
Name Time Method Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score at Week 3 Baseline, 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.
Trial Locations
- Locations (66)
Forest Investigative Site 025
🇺🇸St. Louis, Missouri, United States
Forest Investigative Site 206
🇷🇴Bucuresti, Romania
Forest Investigative Site 307
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 306
🇺🇦Lugansk, Ukraine
Forest Investigative Site 311
🇺🇦Lviv, Ukraine
Forest Investigative Site 401
🇷🇸Senta, Serbia
Forest Investigative Site 310
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 303
🇺🇦Kyiv, Ukraine
Forest Investigative Site 312
🇺🇦Kyiv, Ukraine
Forest Investigative Site 016
🇺🇸New Britain, Connecticut, United States
Forest Investigative Site 017
🇺🇸San Diego, California, United States
Forest Investigative Site 018
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 021
🇺🇸Greenwood, Indiana, United States
Forest Investigative Site 024
🇺🇸Santa Ana, California, United States
Forest Investigative Site 001
🇺🇸Shreveport, Louisiana, United States
Forest Investigative Site 607
🇭🇷Rijeka, Croatia
Forest Investigative Site 605
🇭🇷Zagreb, Croatia
Forest Investigative Site 007
🇺🇸Washington, District of Columbia, United States
Forest Investigative Site 004
🇺🇸Irving, Texas, United States
Forest Investigative Site 602
🇭🇷Zagreb, Croatia
Forest Investigative Site 023
🇺🇸San Diego, California, United States
Forest Investigative Site 013
🇺🇸Honolulu, Hawaii, United States
Forest Investigative Site 010
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 026
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 019
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 002
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 606
🇭🇷Zagreb, Croatia
Forest Investigative Site 005
🇺🇸Oceanside, California, United States
Forest Investigative Site 502
🇷🇺Smolensk, Russian Federation
Forest Investigative Site 012
🇺🇸Cerritos, California, United States
Forest Investigative Site 003
🇺🇸Orlando, Florida, United States
Forest Investigative Site 011
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 006
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 504
🇷🇺Saratov, Russian Federation
Forest Investigative Site 204
🇷🇴Targoviste, Dambovita, Romania
Forest Investigative Site 304
🇺🇦Kyiv, Ukraine
Forest Investigative Site 302
🇺🇦Odessa, Ukraine
Forest Investigative Site 210
🇷🇴Craiova, Dolj, Romania
Forest Investigative Site 201
🇷🇴Craiova, Romania
Forest Investigative Site 501
🇷🇺Lipetsk, Russian Federation
Forest Investigative Site 205
🇷🇴Bucuresti, Romania
Forest Investigative Site 202
🇷🇴Constanta, Romania
Forest Investigative Site 503
🇷🇺Moscow, Russian Federation
Forest Investigative Site 510
🇷🇺Moscow, Russian Federation
Forest Investigative Site 403
🇷🇸Belgrade, Serbia
Forest Investigative Site 308
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 402
🇷🇸Kragujevac, Serbia
Forest Investigative Site 507
🇷🇺Moscow, Russian Federation
Forest Investigative Site 506
🇷🇺Saint Petersburg, Russian Federation
Forest Investigative Site 508
🇷🇺Saint Petersburg, Russian Federation
Forest Investigative Site 509
🇷🇺Samara, Russian Federation
Forest Investigative Site 405
🇷🇸Belgrade, Serbia
Forest Investigative Site 301
🇺🇦Donetsk, Ukraine
Forest Investigative Site 305
🇺🇦Kyiv, Ukraine
Forest Investigative Site 211
🇷🇴Timisoara, Timis, Romania
Forest Investigative Site 209
🇷🇴Arad, Romania
Forest Investigative Site 203
🇷🇴Bucharest, Romania
Forest Investigative Site 208
🇷🇴Bucuresti, Romania
Forest Investigative Site 212
🇷🇴Focsani, Vrancea, Romania
Forest Investigative Site 404
🇷🇸Belgrade, Serbia
Forest Investigative Site 309
🇺🇦Kyiv, Ukraine
Forest Investigative Site 314
🇺🇦Poltava, Ukraine
Forest Investigative Site 315
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 008
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 015
🇺🇸Memphis, Tennessee, United States
Forest Investigative Site 014
🇺🇸Bothell, Washington, United States