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NCT00192855 Clinical Trial

Entacapone Augmentation for Schizophrenia

Schizophrenia Clinical Trial

Official title:
Entacapone Augmentation for Schizophrenia- A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00192855
Other study ID # entacapon.schiz.CTIL
Secondary ID
Status Completed
Phase N/A
First received September 13, 2005
Last updated August 24, 2010
Start date June 2003
Est. completion date October 2006

Study information
Verified date September 2005
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- predominantly negative symptoms

- stable on ongoing antipsychotic treatment

Exclusion Criteria:

- acute psychotic exacerbation

- suicidal ideation

- uncontrolled systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Entacapone
Entacapone 600mg BID

Locations
Country Name City State
Israel Rambam medical center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in specific rating scales during the study and after completion, compared to baseline. Baseline and once a month untill end of study No
Secondary Change in PANSS score. Before and after intervention No
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