6-WEEK TRIAL OF THE EFFICACY AND SAFETY OF ASENAPINE COMPARED TO RISPERIDONE IN ADULT PATIENT WITH ACUTE EXACERBATION OF SCHIZOPHRENIA

Phase 3

Completed

• Conditions: Health Condition 1: null- ACUTE EXACERBATION OF SCHIZOPHRENIA

• Registration Number: CTRI/2010/091/000423
• Lead Sponsor: Intas Pharmaceuticals Limited

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: 280

Inclusion Criteria

1)Patients of either sex between 18 and 65 years of age, with acute exacerbation of schizophrenia as per DSM-IV-TR (In case of female with child bearing potential: surgically sterile or using a medically accepted means of contraception with negative serum pregnancy test)

2)Patient or his/her legally acceptable representative willing to provide written informed consent

3)Patient must have a legally acceptable representative who could provide support to the patient to ensure compliance with study treatment and study visits

4)Patients must have a current acute exacerbation of Schizophrenia as evidenced by a Positive and Negative Syndrome Scale (PANSS) score of greater or equal to 60 at both screening and baseline, a Clinical Global Impression of Severity (CGI-S) score of greater or equal to 4 (moderately ill) at baseline, and a PANSS items scores of greater or equal to 4 on at least two of the five core positive symptoms items (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, and suspiciousness /persecution) at screening and baseline.

5)Patients must have responded previously to an antipsychotic drug other than clozapine, if they had been treated previously with antipsychotic medication

Exclusion Criteria

1)Baseline total PANSS score < 80 percentage of the screening PANSS score
2)Pregnancy and lactation
3)Diagnosis of residual subtype of schizophrenia or shizoaffective disorder (as per DSM-IV-TR)
4)Primary psychiatric diagnosis other than schizophrenia (as per DSM-IV-TR)
5)A score of > 2 (mild) on any item of the Abnormal Involuntary Movement Scale (AIMS) at screening
6)Parkinson?s disease
7)Hyperglycemia (Random blood sugar > or = 140 mg/dL) or diabetes mellitus
8)History of signs and symptoms of orthostatic hypotension i.e. syncope
9)History of drug induced leucopenia/neutropenia/agranulocytosis
10)Cardiac arrhythmia, QT prolongation or conditions predisposing for prolongation of QT interval i.e. bradycardia, dehydration or hypokalemia
11)Hyperprolactinemia (serum prolactin level >30 ng/mL) or disease conditions augmented by elevated serum prolactin levels, e.g., breast cancer or pheochromocytoma
12)History of suicidal tendency
13)History of seizure disorder
14)History of alcohol or drug abuse
15)Hepatic function impairment (SGPT or SGOT level > or = 2.5 times upper normal limit) renal function impairment (serum creatinine > or = 1.5 times upper normal limit)
16)Ongoing treatment with prohibited medications, viz. other antipsychotic drugs, other psychotropic medication, dopaminergic agonists, drugs prolonging QTc interval, drugs causing bradycardia, drugs causing electrolyte imbalance, &#945;1-antagonists, strong CYP1A2 inhibitors or any investigational drug.
17)Deemed inappropriate for enrollment by investigating physician due to other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the total PANSS scoreTimepoint: Change at the end of trial will be compared with baseline.

Secondary Outcome Measures

Name	Time	Method
1.Change in negative subscale score (PANSS) <br/ ><br>2.Change in positive subscale score (PANSS) <br/ ><br>3.Change in CGI-S score <br/ ><br>Timepoint: Change at the end of trial will be compared with baseline.