Efficacy of Selegiline in Negative Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00456976
First received: April 4, 2007
Last updated: July 22, 2008
Last verified: July 2008
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00456976     History of Changes
Other Study ID Numbers: 8514, tums
Study First Received: April 4, 2007
Last Updated: July 22, 2008
Health Authority: Iran: Tabriz University of Medical Sciences

Keywords provided by Tabriz University:
Seligiline
Negative symptoms
Schizopherenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014