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Entacapone Augmentation for Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Entacapone
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, negative symptoms, entacapone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 13, 2005
Last Updated
August 24, 2010
Sponsor
Rambam Health Care Campus
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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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