Long-term Study of Cariprazine in Patients With Schizophrenia
- Registration Number
- NCT01104792
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 752
- Patients and corresponding caregivers who have provided informed consents 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 schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID).
- Patients with normal physical examination, laboratory, vital signs, and electrocardiogram (ECG).
- Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cariprazine Cariprazine Participants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 48 in the PANSS Total Score Baseline to Week 48 The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.
- Secondary Outcome Measures
Name Time Method Change From Baseline to Week 48 in the CGI-S Score Baseline to Week 48 The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.
Trial Locations
- Locations (86)
Forest Investigative Site 044
🇺🇸Rockville, Maryland, United States
Forest Investigative Site 007
🇺🇸Flowood, Mississippi, United States
Forest Investigative Site 082
🇺🇸North Miami, Florida, United States
Forest Investigative Site 602
🇨🇴Bogota, Colombia
Forest Investigative Site 105
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 505
🇮🇳Vijaywada, India
Forest Investigative Site 084
🇺🇸DeSoto, Texas, United States
Forest Investigative Site 604
🇨🇴Pereira, Risaralda, Colombia
Forest Investigative Site 306
🇷🇴Bucuresti, Romania
Forest Investigative Site 072
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 021
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 014
🇺🇸Springdale, Arkansas, United States
Forest Investigative Site 080
🇺🇸Carson, California, United States
Forest Investigative Site 518
🇮🇳Lucknow, India
Forest Investigative Site 517
🇮🇳Mangalore, India
Forest Investigative Site 515
🇮🇳Mangalore, India
Forest Investigative Site 510
🇮🇳Mumbai, India
Forest Investigative Site 513
🇮🇳Nashik, India
Forest Investigative Site 300
🇷🇴Craiova, Romania
Forest Investigative Site 050
🇺🇸Long Beach, California, United States
Forest Investigative Site 079
🇺🇸Cerritos, California, United States
Forest Investigative Site 022
🇺🇸Garden Grove, California, United States
Forest Investigative Site 008
🇺🇸Hoffman Estates, Illinois, United States
Forest Investigative Site 017
🇺🇸Creve Coeur, Missouri, United States
Forest Investigative Site 076
🇺🇸Saint Charles, Missouri, United States
Forest Investigative Site 045
🇺🇸Saint Louis, Missouri, United States
Forest Investigative Site 605
🇨🇴Bogota, Colombia
Forest Investigative Site 500
🇮🇳Aurangabad, India
Forest Investigative Site 100
🇷🇺Tomsk, Russian Federation
Forest Investigative Site 211
🇺🇦Glevakha, Kyiv Region, Ukraine
Forest Investigative Site 203
🇺🇦Kharkov, Ukraine
Forest Investigative Site 506
🇮🇳Varanasi, India
Forest Investigative Site 303
🇷🇴Targoviste, Romania
Forest Investigative Site 104
🇷🇺Chita, Russian Federation
Forest Investigative Site 113
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 107
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 208
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 201
🇺🇦Kyiv, Ukraine
Forest Investigative Site 202
🇺🇦Lviv, Ukraine
Forest Investigative Site 207
🇺🇦Vinnytsya, Ukraine
Forest Investigative Site 507
🇮🇳Kanpur, India
Forest Investigative Site 311
🇷🇴Craiova, Romania
Forest Investigative Site 102
🇷🇺Arkhangelsk, Russian Federation
Forest Investigative Site 205
🇺🇦Dnipropetrovsk, Ukraine
Forest Investigative Site 209
🇺🇦Poltava, Ukraine
Forest Investigative Site 519
🇮🇳Ahmedabad, India
Forest Investigative Site 501
🇮🇳Ahmedabad, India
Forest Investigative Site 304
🇷🇴Targu Mures, Romania
Forest Investigative Site 103
🇷🇺Chelyabinsk, Russian Federation
Forest Investigative Site 110
🇷🇺Saratov, Russian Federation
Forest Investigative Site 112
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 106
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 109
🇷🇺St. Petersburg, Russian Federation
Forest Investigative Site 204
🇺🇦Kharkiv, Ukraine
Forest Investigative Site 301
🇷🇴Cluj-Napoca, Romania
Forest Investigative Site 503
🇮🇳Ahmedabad, India
Forest Investigative Site 509
🇮🇳Rajkot, India
Forest Investigative Site 108
🇷🇺Saratov, Russian Federation
Forest Investigative Site 206
🇺🇦Kherson, Stepanivka, Ukraine
Forest Investigative Site 200
🇺🇦Donetsk, Ukraine
Forest Investigative Site 210
🇺🇦Simferopol, Ukraine
Forest Investigative Site 070
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 071
🇺🇸New Britain, Connecticut, United States
Forest Investigative Site 048
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 003
🇺🇸Riverside, California, United States
Forest Investigative Site 016
🇺🇸San Diego, California, United States
Forest Investigative Site 073
🇺🇸Santa Ana, California, United States
Forest Investigative Site 002
🇺🇸Bradenton, Florida, United States
Forest Investigative Site 041
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 055
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 087
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 012
🇺🇸Honolulu, Hawaii, United States
Forest Investigative Site 018
🇺🇸Chicago, Illinois, United States
Forest Investigative Site 052
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 004
🇺🇸Willingboro, New Jersey, United States
Forest Investigative Site 077
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 047
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 074
🇺🇸Austin, Texas, United States
Forest Investigative Site 086
🇺🇸Little Rock, Arkansas, United States
Forest Investigative Site 083
🇺🇸Garden Grove, California, United States
Forest Investigative Site 006
🇺🇸Oceanside, California, United States
Forest Investigative Site 040
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 019
🇺🇸Willoughby, Ohio, United States
Forest Investigative Site 043
🇺🇸Irving, Texas, United States
Forest Investigative Site 078
🇺🇸Bellevue, Washington, United States
Forest Investigative Site 601
🇨🇴Bello, Antioquia, Colombia