A clinical trial to study the effects of two antipsychotic agents in adult patients with schizophrenia.

Phase 3

Completed

• Registration Number: CTRI/2010/091/000562
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. Male or female patients aged between 18 and 65 years.
2. Has a primary diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders IV Text Revision (DSM-IV TR).
3. Patient or his/her care taker willing to give their informed consent.

Exclusion Criteria

1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2. Patients having hypersensitivity to investigational products or any of the excipients of this formulation.
3. Patients taking drugs that are known to prolong QTc interval.
4. Patients with a history of cardiac arrhythmias.
5. Patients having severe renal and hepatic impairment.
6. Patients who displayed marked suicidal intent or known suicidal tendencies.
7. Alcohol abused patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average change in total score of Positive Symptoms and Negative Symptoms using PANSS.Timepoint: Day 0, Day 14, Day 42

Secondary Outcome Measures

Name	Time	Method
1. Average change from baseline to end of trial in Clinical Global Impression on Severity (CGI-S). <br>2. Clinical Global Impression on Improvement (CGI-I) in patients.<br>Timepoint: 1. Day 0, Day 42,<br>2. Day 14, Day 42.<br>