A clinical trial to study to assess effectiveness and safety of two medications for the treatment for schizophrenia
- Conditions
- Health Condition 1: null- SchizophreniaHealth Condition 2: F209- Schizophrenia, unspecified
- Registration Number
- CTRI/2011/091/000140
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Patients between 18-65 years of age.
2.Patients with diagnosis of schizophrenia.
3.Informed consent.
1.Pregnancy and/or lactation.
2.Patients with suicidal tendencies.
3.Patients with relevant CNS disorders or history of such disorders.
4.Patients with a history of neuroleptic malignant syndrome (NMS).
5.Patients with uncontrolled diabetes or significant cardiovascular diseases.
6.Patients with angle-closure glaucoma, benign prostatic hyperplasia, urinary retention or paralytic ileus.
7.Patients with significant renal or hepatic impairment, acute infections, leucopenia, hyperthyroidism or SIADH.
8.Impoverished patients.
9.Patients with an organic psychiatric disorder.
10.History of hypersensitivity to study medication.
11.Patients requiring concomitant treatment which is not permissible.
12.Patients with any other serious concurrent illness or malignancy.
13.Patients with continuing history of alcohol and/or drug abuse.
14.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of improvement in the PANSS total scoreTimepoint: Baseline, monthly & at the end of study
- Secondary Outcome Measures
Name Time Method (1)The degree of improvement in the PANSS factor scores <br/ ><br>(2)The degree of improvement in the Clinical Global Impressions (CGI) ? severity and improvement scoresTimepoint: Baseline, monthly & at the end of study