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Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia (25543)(COMPLETED)(P05817)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00212836
First received: September 13, 2005
Last updated: April 28, 2017
Last verified: April 2017
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Purpose
Treatment with conventional antipsychotics such as haloperidol has little effect or may sometimes even worsen negative symptoms (such as blunted affect, emotional withdrawal, and poor rapport) of schizophrenia. The newer "atypical" antipsychotics agents, such as olanzapine, have shown improvement in the treatment of negative symptoms in acute trials. The purpose of this study is to compare an investigational compound (asenapine) with a marketed agent (olanzapine) in the treatment of stable subjects with persistent negative symptoms of schizophrenia for 6 months. Patients completing this study may be eligible to participate in an extension 6 months of treatment. Patients are required to have stable symptoms prior to entry into study.
| Condition | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: asenapine Drug: olanzapine | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Flexible -Dose, 6-Month Trial Comparing the Efficacy Safety of Asenapine With Olanzapine in Stable Subjects With Predominant, Persistent Negative Symptoms of Schizophrenia |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
U.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Changes from baseline at 6-months in Negative symptoms of schizophrenia measured by the Negative Symptoms Assessment (NSA) scale [ Time Frame: Change from baseline at 6-months ]
Secondary Outcome Measures:
- Change from baseline at 6-months in quality of life measured by the Quality of Life (QLS) scale [ Time Frame: Change from baseline at 6-months ]
- Positive and negative symptoms and other symptoms of schizophrenia e.g., hostility, excitement, disorganized thoughts and cognition measured by the Positive and Negative Symptom Scale (PANSS) [ Time Frame: Change from baseline at 6-months ]
- Depressive symptoms measured by the Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Change from baseline at 6-months ]
- Overall clinical global impression of severity improvement measured by the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) [ Time Frame: Change from baseline at 6-months ]
| Enrollment: | 481 |
| Actual Study Start Date: | April 21, 2005 |
| Study Completion Date: | August 2, 2007 |
| Primary Completion Date: | June 15, 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Asenapine |
Drug: asenapine
5-10 mg sublingually twice daily for 26 weeks
|
| Active Comparator: Olanzapine |
Drug: olanzapine
5-20 mg by mouth once daily for 26 weeks
Other Name: Zyprexa
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a documented current diagnosis of schizophrenia of paranoid, disorganized, catatonic, residual, or undifferentiated subtype with persistent negative symptoms.
- No increase in level of psychiatric care during the past few months due to worsening of symptoms of schizophrenia.
- Caregiver required.
Exclusion Criteria:
- Have an uncontrolled, unstable clinically significant medical condition.
- Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.
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More Information
Publications:
Study Data/Documents: CSR Synopsis
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00212836 History of Changes |
| Other Study ID Numbers: |
P05817 Aphrodite; 25543 |
| Study First Received: | September 13, 2005 |
| Last Updated: | April 28, 2017 |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Olanzapine Asenapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |
ClinicalTrials.gov processed this record on August 22, 2017