Fixed Dose Efficacy and Safety Study of Asenapine for the Treatmentof Schizophrenia in Adolescents

Phase 3

Completed

• Conditions: Health Condition 1: null- Schizophrenia, Paranoid; Schizophrenia, Disorganized; Schizophrenia, UndifferentiatedHealth Condition 2: F209- Schizophrenia, unspecifiedHealth Condition 3: F209- Schizophrenia, unspecified

• Registration Number: CTRI/2011/07/001909
• Lead Sponsor: Merck Sharp and Dohme

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: 300

Inclusion Criteria

Each participant must have schizophrenia.

- Each participant must be greater than or equal to 12 years of age and less than 18 years of age.

- Each participant must have a minimum Positive and Negative Syndrome Scale (PANSS) total score of 80.

- Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior,

grandiosity, suspiciousness/ persecution) at Screening and Baseline.

- Each participant must have a Clinical Global Impression of Severity (CGI-S) scale score of greater than or equal to 4 at Screening and Baseline.

- Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers)

Exclusion Criteria

- A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with continuous, single episode in

partial remission, or single episode in full remission course specifiers.

- A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.

- A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.

- A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria for substance abuse or dependence (excluding nicotine).

- A participant must not be at imminent risk of self-harm or harm to others, in the investigators opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total scoreTimepoint: Day 56

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Global Impression of Severity (CGI-S) scoreTimepoint: Day 56;Proportion of total PANSS 30 percent respondersTimepoint: Day 56