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Treatment of Post-TBI Depression

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00233103
First received: October 3, 2005
Last updated: March 7, 2012
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Depression
Drug: Sertraline
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Post-TBI Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Depression [ Time Frame: immediately post-intervention ] [ Designated as safety issue: No ]
    self-report of depression and DSM-IV diagnosis


Secondary Outcome Measures:
  • BAI [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]
    Anxiety

  • Life-3 [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]
    Quality of life


Enrollment: 52
Study Start Date: June 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline
Sertraline
Drug: Sertraline
Sertraline arm
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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
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: 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
U.S. Department of Education
Investigators
Principal Investigator: Wayne Gordon, Ph.D. Mount Sinai School of Medicine
  More Information

No publications provided by Mount Sinai School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00233103     History of Changes
Other Study ID Numbers: GCO 02-0677, H133A020501
Study First Received: October 3, 2005
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014