Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury — Duloxetine  

Depression Clinical Trial

Official title: Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine

Status Terminated

Clinical Trial Summary

The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.

Clinical Trial Description

The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Depression
• Depressive Disorder
• Traumatic Brain Injury

• NCT number: NCT01223001
• Study type: Interventional
• Source: Rehabilitation Hospital of Indiana
• Status: Terminated
• Phase: Phase 2
• Start date: September 1996
• Completion date: July 2011