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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
History of Changes
  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:

MedlinePlus related topics: Schizophrenia
Drug Information available for: Entacapone
U.S. FDA Resources

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 May 23, 2013