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Efficacy of Selegiline in Negative Symptoms of Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00456976
First Posted: April 5, 2007
Last Update Posted: July 23, 2008
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:
Tabriz University
  Purpose

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.


Condition Intervention Phase
Schizophrenia Drug: Selegiline Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • decreasing in negative symptoms in case group

Estimated Enrollment: 70
Study Start Date: April 2007
Estimated Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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): NCT00456976


Locations
Iran, Islamic Republic of
Razi university hospital
Tabriz, East Azarbaijan, Iran, Islamic Republic of, 5167846184
Sponsors and Collaborators
Tabriz University
Investigators
Study Chair: Fatemeh Ranjbar Kouchaksaraei, Assistant Professor Tabriz University of Medical Sciences
  More Information

ClinicalTrials.gov Identifier: NCT00456976     History of Changes
Other Study ID Numbers: 8514
tums
First Submitted: April 4, 2007
First Posted: April 5, 2007
Last Update Posted: July 23, 2008
Last Verified: July 2008

Keywords provided by Tabriz University:
Seligiline
Negative symptoms
Schizopherenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders