The purpose of the study is to determine whether Cariprazine is a safe and tolerated long-term treatment in patients with chronic stable schizophrenia.

Phase 2

Completed

• Conditions: Schizophrenia

• Registration Number: CTRI/2009/091/000395
• Lead Sponsor: Forest Research Institute Inc

Brief Summary

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with Schizophrenia. Study Methodology: International, multicenter, open-label, flexible dose, extension to study RGH-MD-16 (lead-in study) a randomized, double-blind, active controlled, parallel group study in patients with acute exacerbation of schizophrenia. The primary outcomes measures of the study includes: Clinical laboratory, Electrocardiogram, Adverse events, Physical Examinations and Extrapyramidal symptomatology. In India, we are planning to enroll approximately 125 patients. The first patient screening date in India was June 20, 2009.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-20
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients who have completed the double-blind treatment period of the lead-in study (RGH-MD-16).
• Patients who have responded to double-blind treatment in the lead-in study as outpatients (As demonstrated by at least a 20% reduction in PANSS total score relative to Visit 2 of the lead-in study and a CGI-S score of less than or equal to 3).
• Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
• Patients must have a caregiver to ensure treatment compliance.

Exclusion Criteria

Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/ or ECG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Electrocardiogram	During conduct of the study
- Clinical laboratory	During conduct of the study
- Adverse events	During conduct of the study
- Extrapyramidal symtomatology	During conduct of the study
- Physical Examinations	During conduct of the study

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not Applicable

Trial Locations

Locations (12)

Abhaya Hospital,; 🇮🇳 Bangalore, KARNATAKA, India

Deenanath Mangeshkar Hospital & Research Centre,; 🇮🇳 Pune, MAHARASHTRA, India

Government Hospital for Mental Care,; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Gujarat Institute of Psychological Sciences and Research (GIPS),; 🇮🇳 Ahmadabad, GUJARAT, India

JSS Medical College Hospital,; 🇮🇳 Mysore, KARNATAKA, India

Kasturba Hospital,; 🇮🇳 ,-576, India

Kasturba Medical College & Hospital (KMH),; 🇮🇳 Bangalore, KARNATAKA, India

Mahendru Psychiatric Centre,; 🇮🇳 117/40,, ,Sarvodayanagar,, India

Mental Illness Treatment Rehabilitation Foundation (MITR),; 🇮🇳 Ahmadabad, GUJARAT, India

R.K.Yadav Memorial Mental Health & De-Addiction Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Scroll for more (2 remaining)

Abhaya Hospital,

🇮🇳Bangalore, KARNATAKA, India

Dr. A. Jagadish

Principal investigator

80-26564586

a_jagadish@yahoo.com