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

Condition(s) targeted: Traumatic Brain Injury; Depression

Intervention: Duloxetine (Drug); Sugar pill (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Rehabilitation Hospital of Indiana

Official(s) and/or principal investigator(s):
Lance Trexler, Ph.D., Principal Investigator, Affiliation: Rehabilitation Hospital of Indiana

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.

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

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

Primary outcome: Hamilton Rating Scale for Depression

Secondary outcome: Hopkins Verbal Learning Test

Detailed 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.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Study participants will be 40 men and women between the ages of 18 and 75 who provide

appropriate consent and who are agreeable to study requirements

- Diagnosed with mild to moderate traumatic brain injury as defined by an

initial Mayo Traumatic Brain Injury Severity Scale

- Have memory impairments defined by a Hopkins Verbal Learning Test delayed recall

score which falls less than or equal to 1. 5 standard deviation below the mean. Exclusion Criteria:

- Refusal to give informed consent

- A previous Central Nervous System illness or injury, including seizure that exhibits

residual symptoms.

- Current post-traumatic seizure disorder

- A previous diagnosis of a psychotic disorder

- Current or previous (in the last 6 months) treatment history for alcohol or substance

dependency

- Medications affecting noradrenergic or dopaminergic systems, alpha-adrenergic

antihypertensives, antidepressant, phenobarbital, Monoamine oxidase inhibitor (MAOI), scheduled benzodiazepines, psychoactive herbal supplements (including Kava, St. John's wort), or nutritional supplements or within at least 14 days of discontinuing treatment with the above medications or supplements.

- A known suicide risk

- A pregnant or breastfeeding woman

- Uncontrolled narrow-angle glaucoma

- Serious and/or unstable medical comorbidity (e. g., AIDS, cancer, history of

uncontrolled hypertension or cardiovascular disease) psychological condition, or clinically significant laboratory abnormality that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study

- Liver enzymes > 1. 5 times upper limit of normal

- Patients with end-stage renal disease (requiring dialysis) or severe renal impairment

- Known hypersensitivity to duloxetine or any of the inactive ingredients

Rehabilitation Hospital of Indiana, Indianapolis, Indiana 46254, United States

Starting date: September 1996
Last updated: December 15, 2014