A clinical trial to study the effects of two drugs, asenapine and risperidone in the acute treatment of schizophrenia.

Evaluation of efficacy and safety of asenapine versus risperidone in the acute treatment of schizophrenia: a randomized, open label, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000663

Enrollment

200

Registered

2010-06-30

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Asenapine: 5 mg twice daily Control Intervention1: Risperidone: 2 mg to 8 mg per day

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactDr. Surendra Borgharkar

medical.services@sunpharma.com02266969696

Outcome results