Safety and Efficacy of Cariprazine in Schizophrenia
- Registration Number
- NCT01104779
- Lead Sponsor
- Forest Laboratories
- Brief Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 446
- 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 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)
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
- Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
- Patients in their first episode of psychosis
- Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Substance abuse or dependence within the prior 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo Cariprazine (6-9 mg/day) Cariprazine Cariprazine once daily fixed-flexible high dose Cariprazine (3-6 mg/day) Cariprazine Cariprazine once daily fixed-flexible low dose
- Primary Outcome Measures
Name Time Method Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score Baseline to Week 6 The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.
- Secondary Outcome Measures
Name Time Method Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Baseline to 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.
Trial Locations
- Locations (41)
Forest Investigative Site 503
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 604
🇨🇴Pereira, Risaralda, Colombia
Forest Investigative Site 505
🇮🇳Vijayawada, Andhra Pradesh, India
Forest Investigative Site 601
🇨🇴Bello, Antioquia, Colombia
Forest Investigative Site 507
🇮🇳Kanpur, Uttar Pradesh, India
Forest Investigative Site 517
🇮🇳Mangalore, Karna, India
Forest Investigative Site 500
🇮🇳Aurangabad, Mahara, India
Forest Investigative Site 510
🇮🇳Mumbai, Mahara, India
Forest Investigative Site 50
🇺🇸Long Beach, California, United States
Forest Investigative Site 42
🇺🇸Paramount, California, United States
Forest Investigative Site 41
🇺🇸Kissimmee, Florida, United States
Forest Investigative Site 48
🇺🇸Costa Mesa, California, United States
Forest Investigative Site 45
🇺🇸Saint Louis, Missouri, United States
Forest Investigative Site 054
🇺🇸San Diego, California, United States
Forest Investigative Site 52
🇺🇸Las Vegas, Nevada, United States
Forest Investigative Site 47
🇺🇸Philadelphia, Pennsylvania, United States
Forest Investigative Site 602
🇨🇴Bogota, Colombia
Forest Investigative Site 504
🇮🇳Bangalore, Karna, India
Forest Investigative Site 502
🇮🇳Pune, Mahara, India
Forest Investigative Site 501
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 605
🇨🇴Bogota, Colombia
Forest Investigative Site 514
🇮🇳Visakhapatnam, Andhra Pradesh, India
Forest Investigative Site 515
🇮🇳Mangalore, Karna, India
Forest Investigative Site 519
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 508
🇮🇳Ahmedabad, Gujarat, India
Forest Investigative Site 516
🇮🇳Mysore, Karna, India
Forest Investigative Site 513
🇮🇳Nashik, Mahara, India
Forest Investigative Site 511
🇮🇳Pune, Mahara, India
Forest Investigative Site 509
🇮🇳Rajkot, Rajastan, India
Forest Investigative Site 518
🇮🇳Lucknow, Uttar Pradesh, India
Forest Investigative Site 506
🇮🇳Varanasi, Uttar Pradesh, India
Forest Investigative Site 704
🇿🇦Johannesburg, Gauteng, South Africa
Forest Investigative Site 703
🇿🇦Cape Town, W Cape, South Africa
Forest Investigative Site 706
🇿🇦Cape Town, W Cape, South Africa
Forest Investigative Site 46
🇺🇸Cincinnati, Ohio, United States
Forest Investigative Site 43
🇺🇸Irving, Texas, United States
Forest Investigative Site 40
🇺🇸Cedarhurst, New York, United States
Forest Investigative Site 51
🇺🇸Houston, Texas, United States
Forest Investigative Site 055
🇺🇸Atlanta, Georgia, United States
Forest Investigative Site 44
🇺🇸Rockville, Maryland, United States
Forest Investigative 49
🇺🇸Memphis, Tennessee, United States