Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

Phase 3

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: asenapine; Drug: olanzapine

• Registration Number: NCT00212784
• Lead Sponsor: Organon and Co

Brief Summary

The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09-04
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2006-03-15
• Study Completion: 2006-03-15
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1225

Inclusion Criteria

• Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.

Read More

Exclusion Criteria

• Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	asenapine	-
Arm 2	olanzapine	-

Primary Outcome Measures

Name	Time	Method
Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline	Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)

Secondary Outcome Measures

Name	Time	Method
Blood Test	At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)	At endpoint
Resource utilization (as measured by frequency and length of hospital stay)	During the study period
Changes in PANSS subscale scores and Marder factor scores	At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
Population kinetics	Plasma samples at weeks 2 and 6 in comparison with baseline
Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)	During the study period
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)	At weeks 8, 20, 28, 36, 44 and endpoint
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)	At weeks 6, 28 and endpoint
Safety and tolerability: EPS (AIMS, BARS, SARS)	At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
Weight and vital signs	at all assessment time points from baseline
Changes in CGI-S	At each assessment time point from baseline
Adverse Events	continuously and up to 7 days after endpoint
Pregnancy Test	At endpoint
ECGs	Weeks 3, 6, 24, and endpoint