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Treatment of Post-Traumatic Brain Injury (TBI) Depression

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00233103
First Posted: October 5, 2005
Last Update Posted: November 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Post-TBI Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Depression at Baseline [ Time Frame: baseline ]

    The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.

    Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline.


  • Depression at End of Treatment [ Time Frame: end of treatment, average of 10 weeks ]

    Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention.

    The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.



Secondary Outcome Measures:
  • BAI [ Time Frame: Immediately post-intervention ]
    The Beck Anxiety Inventory (BAI) is a 21-item self-report measure that assesses subjective, somatic, or panic-related symptoms associated with anxiety rated on a scale from 0 (not at all) to 3(severely). Total score: 0-7 = minimal level of anxiety, 8-15 = mild anxiety, 16-25 = moderate anxiety, and 26-63 = severe depression

  • Life-3 [ Time Frame: Immediately post-intervention at 10 weeks ]
    Life-3 is a single-item Quality of life (QOL) measure that uses a 7-point Likert-type scale to assess satisfaction with life during the past month. It is typically administered twice during an evaluation, and the mean of the 2 obtained scores is used. Higher scores on this measure indicate higher levels of subjective QOL. Range from 1 to 7.


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
Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg).
Drug: Sertraline
Sertraline arm
Placebo Comparator: Placebo
Placebo for 10 weeks.
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 selective serotonin reuptake inhibitor (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging)
  • at least 6 months post-injury
  • English-speaking
  • residential telephone service
  • living within 1.5 hours of New York City
  • able to comprehend or answer verbal or written questionnaires
  • willing to provide consent to participate in a 12 week drug study to treat Major Depressive Disorder (MDD); current MDD as diagnosed using Structured Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Disorders (SCID), and severity of MDD rated at least 18 on the HAM-D.

Exclusion Criteria:

  • currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs)
  • unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study
  • currently in psychotherapy
  • active suicidal plans and/or requiring hospitalization
  • prior use of sertraline
  • currently experiencing other serious medical illness
  • currently pregnant or breast feeding
  • mass brain lesions or other neurological diagnoses other than TBI
  • history of current or past psychosis or mania
  • current substance abuse
  • history of clinically significant liver or renal disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233103


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
U.S. Department of Education
Investigators
Principal Investigator: Wayne Gordon, Ph.D. Icahn School of Medicine at Mount Sinai
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00233103     History of Changes
Other Study ID Numbers: GCO 02-0677
H133A020501
First Submitted: October 3, 2005
First Posted: October 5, 2005
Results First Submitted: July 29, 2013
Results First Posted: November 13, 2015
Last Update Posted: November 13, 2015
Last Verified: October 2015

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs