Entacapone Augmentation for Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00192855
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : August 25, 2010
Information provided by:
Rambam Health Care Campus

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

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Entacapone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial
Study Start Date : June 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Entacapone

Intervention Details:
  • Drug: Entacapone
    Entacapone 600mg BID

Primary Outcome Measures :
  1. 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 Measures :
  1. Change in PANSS score. [ Time Frame: Before and after intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • predominantly negative symptoms
  • stable on ongoing antipsychotic treatment

Exclusion Criteria:

  • acute psychotic exacerbation
  • suicidal ideation
  • uncontrolled systemic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00192855

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

Responsible Party: Ehud Klein, MD, Head Department of Psychiatry, Rambam Medical Center Identifier: NCT00192855     History of Changes
Other Study ID Numbers: entacapon.schiz.CTIL
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: September 2005

Keywords provided by Rambam Health Care Campus:
negative symptoms

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antiparkinson Agents
Anti-Dyskinesia Agents
Catechol O-Methyltransferase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action