Entacapone Augmentation for Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00192855
First received: September 13, 2005
Last updated: August 24, 2010
Last verified: September 2005
  Purpose

This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.


Condition Intervention
Schizophrenia
Drug: Entacapone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in PANSS score. [ Time Frame: Before and after intervention ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: June 2003
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Entacapone
    Entacapone 600mg BID
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • predominantly negative symptoms
  • stable on ongoing antipsychotic treatment

Exclusion Criteria:

  • acute psychotic exacerbation
  • suicidal ideation
  • uncontrolled systemic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192855

Locations
Israel
Rambam medical center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Ehud Klein Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: Ehud Klein, MD, Head Department of Psychiatry, Rambam Medical Center
ClinicalTrials.gov Identifier: NCT00192855     History of Changes
Other Study ID Numbers: entacapon.schiz.CTIL
Study First Received: September 13, 2005
Last Updated: August 24, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
schizophrenia
negative symptoms
entacapone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Entacapone
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014