Efficacy of Selegiline in Negative Symptoms of Schizophrenia

NCT ID: NCT00456976

Last Updated: 2008-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-09-30

Brief Summary

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Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.

Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Seligiline Negative symptoms Schizopherenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Selegiline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe negative symptoms
* Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month.
* No other psychotropic drugs during past month

Exclusion Criteria

* Severe major depressive disorder
* Substance abuse
* Severe positive symptoms of schizophrenia
* Treatment of MDD with antidepressant drugs during past month.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tabriz University

OTHER

Sponsor Role lead

Principal Investigators

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Fatemeh Ranjbar Kouchaksaraei, Assistant Professor

Role: STUDY_CHAIR

Tabriz University of Medical Sciences

Locations

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Razi university hospital

Tabriz, East Azerbaijan Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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tums

Identifier Type: -

Identifier Source: secondary_id

8514

Identifier Type: -

Identifier Source: org_study_id