Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment of Post-TBI Depression
This study has been completed.
Sponsors and Collaborators: Mount Sinai School of Medicine
National Institute of Disability and Rehabilitation Research
Information provided by: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233103
  Purpose

Randomized clinical trial of sertraline vs. placebo for post-TBI depression


Condition Intervention Phase
Depression
Drug: Sertraline
Phase IV

MedlinePlus related topics: Depression
Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Treatment of Post-TBI Depression

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Self-report of depression and DSM-IV diagnosis

Secondary Outcome Measures:
  • Anxiety
  • quality of life

Estimated Enrollment: 50
Study Start Date: June 2003
Study Completion Date: October 2007
Detailed Description:

Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression.

Background: Major depression is experienced by many more people after TBI than prior to injury and more often than in people without a brain injury. Many studies have also shown that this higher than 'normal' incidence looms for many years post TBI. Major depression is associated with a variety of negative outcomes, including poorer functioning in basic activities, reduced employment, elevated divorce rate, reduced social and recreational activity and increased sexual dysfunction.

Need for Research: Of the current drug treatments for major depression, sertraline and similar drugs (known as selective serotonin reuptake inhibitors, or SSRIs) have few side effects in people who have experienced a brain injury and have been shown to be effective in people with no known brain injury. However, information on the impact of SSRIs on post-TBI depression, based on randomized, double-blind studies, is unavailable.

Current Research Activity: Approximately 50 men and women volunteers who are post TBI and currently diagnosed with major depressive disorder are being randomly assigned to a 12-week period of taking Zoloft or a placebo. Over the period of study, participants will have the severity of their depressive symptoms assessed (as well as their symptoms of anxiety); a simple measure of the volunteer's perceived quality of life will be implemented prior to the study and at its termination. It is hypothesized that sertraline will reduce the symptoms of depression and anxiety and will increase the person's perceived quality of life to a significantly greater extent than will the placebo.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-

Criteria for inclusion in the study are: 1) 18 years or older; 2) experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging); 3) at least 6 months post-injury; 4) English-speaking; 5) residential telephone service; 6) living within 1.5 hours of NYC; 6) able to comprehend or answer verbal or written questionnaires; 7) willing to provide consent to participate in a 12 week drug study to treat MDD; current MDD as diagnosed using SCID, and severity of MDD rated at least 18 on the HAM-D.

Exclusion Criteria:

  1. currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs) 2) unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study; 3) currently in psychotherapy, 4) active suicidal plans and/or requiring hospitalization, 5) prior use of sertraline, 6) currently experiencing other serious medical illness; 7) currently pregnant or breast feeding; 8) mass brain lesions or other neurological diagnoses other than TBI; 9) history of current or past psychosis or mania; 10) current substance abuse; and 11) history of clinically significant liver or renal disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233103

Locations
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
National Institute of Disability and Rehabilitation Research
Investigators
Principal Investigator: Wayne Gordon, Ph.D. Nount Sinai School of Medicine
  More Information

study web page  This link exits the ClinicalTrials.gov site

Study ID Numbers: GCO 02-0677, H133A020501
Study First Received: October 3, 2005
Last Updated: October 18, 2007
ClinicalTrials.gov Identifier: NCT00233103  
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Setraline
TBI
depression
SSRI
brain injury

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder
Brain Injuries
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Central Nervous System Agents
Pharmacologic Actions
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009