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Entacapone Augmentation for Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192855
First Posted: September 19, 2005
Last Update Posted: August 25, 2010
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.
Information provided by:
Rambam Health Care Campus
  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
Intervention Model: Factorial Assignment
Masking: Double (Participant, 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 ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: August 25, 2010
Last Verified: September 2005

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

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