A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
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|ClinicalTrials.gov Identifier: NCT00839852|
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Cariprazine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia|
|Actual Study Start Date :||May 31, 2009|
|Actual Primary Completion Date :||August 31, 2010|
|Actual Study Completion Date :||August 31, 2010|
Experimental: Cariprazine 1.5mg
Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability
Cariprazine was supplied in capsules.
Other Name: RGH-188
- Change From Baseline to Week 48 in the PANSS Total Score [ Time Frame: 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.
- Change From Baseline to Week 48 in the CGI-S Score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839852
|Study Director:||Suresh Durgam, MD||Forest Research Institute, a subsidiary of Forest Laboratories, Inc.|