CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 52 enrolled
Drug / intervention
Sertraline +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 18 years or older
  • ✓Documented TBI with loss of consciousness or neuro-imaging evidence of TBI
  • ✓At least 6 months post-injury
  • ✓Current major depressive disorder diagnosed by SCID
Key exclusion· 10
  • ✕Currently taking any antidepressant medication (including MAOIs or TCAs)
  • ✕Prior use of sertraline
  • ✕Currently in psychotherapy
  • ✕Active suicidal plans and/or requiring hospitalization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233103
NCT00233103Phase 2Completed
CompareCT.gov

Treatment of Post-TBI Depression

Icahn School of Medicine at Mount Sinai·interventional·Posted Oct 5, 2005·Updated Nov 13, 2015

In Brief

A Phase 2 clinical trial evaluating Sertraline and Placebo for Depression. Completed, enrolled 52 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsU.S. Department of Education

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2005
Enrollment StartJun 1, 2003
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 20.7 years ago

Interventions

Sertralinedrug

Sertraline arm

Placebodrug

Placebo