- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00192855
Entacapone Augmentation for Schizophrenia
August 24, 2010 updated by: Rambam Health Care Campus
Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial
This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Haifa, Israel, 31096
- Rambam Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- predominantly negative symptoms
- stable on ongoing antipsychotic treatment
Exclusion Criteria:
- acute psychotic exacerbation
- suicidal ideation
- uncontrolled systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in specific rating scales during the study and after completion, compared to baseline.
Time Frame: Baseline and once a month untill end of study
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Baseline and once a month untill end of study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in PANSS score.
Time Frame: Before and after intervention
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Before and after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ehud Klein, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
August 25, 2010
Last Update Submitted That Met QC Criteria
August 24, 2010
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- entacapon.schiz.CTIL
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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