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

Stopped early · Phase 2

Conditions studied: Traumatic Brain Injury, Depression

In brief

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.

Key facts

Study ID

NCT01223001

Run by

Rehabilitation Hospital of Indiana

People needed

8

Starts

1996-09-01

Expected to finish

2011-07-01

Last updated by the study team

2014-12-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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