ong-term Study of Cariprazine in Patients with Schizophrenia.
- Conditions
- Health Condition 1: null- Schizophrenia
- Registration Number
- CTRI/2010/091/001400
- Lead Sponsor
- Forest Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 600
Male or female patients who are 18 to 60 years of age
- Patients who have provided informed consent prior to any study specific procedures
- Completion of the double-blind treatment period of Study RGH-MD-05
- Patients who are eligible to continue as outpatients in the opinion of the Principal Investigator
- Patients with normal physical examination, laboratory, vital signs, and or electrocardiogram (ECG)
- A designated caregiver to accompany the patient at each visit and who has provided informed consent
- Positive result from the blood alcohol test or urine drug screen for prohibited medications
- Patients who have extrapyramidal symptoms that are not adequately controlled by anti-EPS medications in the opinion of the PI
- Patients who are experiencing ongoing, uncontrolled, clinically significant adverse events
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: - adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms, and otherTimepoint: 48 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetics- Plasma concentrations of cariprazine and its metabolites <br/ ><br>Timepoint: 48 weeks <br/ ><br>