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

Evaluation of efficacy and safety of two antipsychotic agents for the acute treatment of schizophrenia in adults: a randomized, open label, active controlled, multicentric study.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000562

Enrollment

200

Registered

2010-06-02

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: IP-007: 1 mg twice daily which can be increased to 12 to 24 mg/day administered twice daily. Control Intervention1: Haloperidol: 5 mg twice daily to 15 mg twice daily

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 or his/her care taker 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 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.

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