Back to resultsEfficacy of Selegiline in Negative Symptoms of Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Selegiline
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Seligiline, Negative symptoms, Schizopherenia
Eligibility 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.
Sites / Locations
- Razi university hospital
Outcomes
Primary Outcome Measures
decreasing in negative symptoms in case group
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00456976
Brief Title
Efficacy of Selegiline in Negative Symptoms of Schizophrenia
Official Title
Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Seligiline, Negative symptoms, Schizopherenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Selegiline
Primary Outcome Measure Information:
Title
decreasing in negative symptoms in case group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatemeh Ranjbar Kouchaksaraei, Assistant Professor
Organizational Affiliation
Tabriz University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Razi university hospital
City
Tabriz
State/Province
East Azarbaijan
ZIP/Postal Code
5167846184
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Selegiline in Negative Symptoms of Schizophrenia
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