- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174265
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)
A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the Safety and Efficacy of Asenapine With Olanzapine in Subjects Who Completed Protocol A7501013
This is an extension study of A7501013 (P05771/NCT00145496) to further test
the efficacy and safety of Asenapine compared with a
marketed agent (olanzapine) in the treatment of patients with
persistent negative symptoms of schizophrenia.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Continue to meet all demographic and procedural
inclusion criteria of the A7501013 trial to enter into
this extension trial.
- Have demonstrated an acceptable degree of compliance
and completed the A7501013 trial, and would benefit
from continued treatment according to the investigator.
Exclusion Criteria:
- Have an uncontrolled, unstable clinically significant
medical condition.
- Have been judged to be medically noncompliant in the
management of their disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: asenapine
|
5-10 mg sublingually twice daily for 26 weeks
|
ACTIVE_COMPARATOR: olanzapine
|
5-20 mg by mouth once daily for 26 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
Time Frame: Baseline of A7501013 to Day 365
|
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia.
Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.
|
Baseline of A7501013 to Day 365
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
Time Frame: Baseline of A7501013 to Day 365
|
The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities).
The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.
|
Baseline of A7501013 to Day 365
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
- Asenapine
Other Study ID Numbers
- P05772
- APHRODITE
- A7501014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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