Health Condition 1: null- Schizophrenia
Conditions
Interventions
Intervention1: Cariprazine: oral flexible dose,administration for 48 weeks
Control Intervention1: Nil: Nil
Sponsors
Forest Research Institute
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: - adverse event recording, clinical laboratory parameters, vital signs, electrocardiograms, and otherTimepoint: 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics- Plasma concentrations of cariprazine and its metabolites Timepoint: 48 weeks | — |
Countries
Colombia, India, Lithuania, Romania, Russian Federation, South Africa, Ukraine, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt. Ltd.,
Outcome results
None listed