NCT00456976

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for early_phase_1 schizophrenia

Timeline
Completed

Started Apr 2007

Shorter than P25 for early_phase_1 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

April 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 23, 2008

Status Verified

July 1, 2008

First QC Date

April 4, 2007

Last Update Submit

July 22, 2008

Conditions

Schizophrenia

Keywords

SeligilineNegative symptomsSchizopherenia

Outcome Measures

Primary Outcomes (1)

  • decreasing in negative symptoms in case group

Interventions

SelegilineDRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe major depressive disorder
  • Substance abuse
  • Severe positive symptoms of schizophrenia
  • Treatment of MDD with antidepressant drugs during past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Razi university hospital

Tabriz, East Azerbaijan Province, 5167846184, Iran

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Fatemeh Ranjbar Kouchaksaraei, Assistant Professor

    Tabriz University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 5, 2007

Study Start

April 1, 2007

Study Completion

September 1, 2007

Last Updated

July 23, 2008

Record last verified: 2008-07

Locations

IR(1)