Entacapone Augmentation for Schizophrenia

This study has been completed.
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
First received: September 13, 2005
Last updated: August 24, 2010
Last verified: September 2005
This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.

Condition Intervention
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

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

Inclusion Criteria:

  • predominantly negative symptoms
  • stable on ongoing antipsychotic treatment

Exclusion Criteria:

  • acute psychotic exacerbation
  • suicidal ideation
  • uncontrolled systemic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192855

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

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:
negative symptoms

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

ClinicalTrials.gov processed this record on May 03, 2016