NCT00192855

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jun 2003

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 25, 2010

Status Verified

September 1, 2005

Enrollment Period

3.3 years

First QC Date

September 13, 2005

Last Update Submit

August 24, 2010

Conditions

Schizophrenia

Keywords

schizophrenianegative symptomsentacapone

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Change in PANSS score.

    Before and after intervention

Interventions

EntacaponeDRUG

Entacapone 600mg BID

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • predominantly negative symptoms
  • stable on ongoing antipsychotic treatment

You may not qualify if:

  • acute psychotic exacerbation
  • suicidal ideation
  • uncontrolled systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam medical center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

entacapone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Ehud Klein

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

June 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 25, 2010

Record last verified: 2005-09

Locations

IL(1)