A clinical trial to study the effects of two drugs, asenapine and risperidone in the acute treatment of schizophrenia.
Phase 3
Completed
- Registration Number
- CTRI/2010/091/000663
- Lead Sponsor
- Sun Pharmaceutical Industries Ltd., ACME Plaza, Andheri Kurla Road (E), Mumbai - 400059. India.
- Brief Summary
Not available
- Detailed Description
Not available
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 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.
3. Patients having untreated or clinically significant renal, endocrine, hepatic, respiratory diseases.
4. Patients with a history of neurologic illness.
5. Patients who displayed marked suicidal intent or known suicidal tendencies.
6. Alcohol abused patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method