Phase 2 N=52 Randomized Double-blind Treatment

Treatment of Post-Traumatic Brain Injury (TBI) Depression

Depression

Bottom Line

View on ClinicalTrials.gov: NCT00233103 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2015

Primary outcome: Primary: Depression at Baseline — 27.5; 25.2 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Sertraline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Depression at Baseline	27.5; 25.2	—
PRIMARY Depression at End of Treatment	13.7; 16.2	—
SECONDARY BAI	11.1; 13.1	—
SECONDARY Life-3	6.3; 4.9	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00233103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.