Entacapone Augmentation for Schizophrenia

• Sponsor: Rambam Health Care Campus (Other)
• Overall Status: Completed
• CT.gov ID: NCT00192855
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2003
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. Improvement in specific rating scales during the study and after completion, compared to baseline. [Baseline and once a month untill end of study]

Secondary Outcome Measures

1. Change in PANSS score. [Before and after intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam medical center	Haifa		Israel	31096

Sponsors and Collaborators

• Rambam Health Care Campus

Investigators

• Principal Investigator: Ehud Klein, Rambam Health Care Campus

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00192855
• Other Study ID Numbers: entacapon.schiz.CTIL
• First Posted: Sep 19, 2005
• Last Update Posted: Aug 25, 2010
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: schizophrenia; negative symptoms; entacapone
• Additional relevant MeSH terms: Schizophrenia; Entacapone

Study Results

No Results Posted as of Aug 25, 2010