Entacapone Augmentation for Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Entacapone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, negative symptoms, entacapone
Eligibility Criteria
Inclusion Criteria: predominantly negative symptoms stable on ongoing antipsychotic treatment Exclusion Criteria: acute psychotic exacerbation suicidal ideation uncontrolled systemic disease
Sites / Locations
- Rambam medical center
Outcomes
Primary Outcome Measures
Improvement in specific rating scales during the study and after completion, compared to baseline.
Secondary Outcome Measures
Change in PANSS score.
Full Information
NCT ID
NCT00192855
First Posted
September 13, 2005
Last Updated
August 24, 2010
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT00192855
Brief Title
Entacapone Augmentation for Schizophrenia
Official Title
Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
5. Study Description
Brief Summary
This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, negative symptoms, entacapone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Entacapone
Intervention Description
Entacapone 600mg BID
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in PANSS score.
Time Frame
Before and after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
predominantly negative symptoms
stable on ongoing antipsychotic treatment
Exclusion Criteria:
acute psychotic exacerbation
suicidal ideation
uncontrolled systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehud Klein
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam medical center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
12. IPD Sharing Statement
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Entacapone Augmentation for Schizophrenia
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