Clinical trial NCT01223001: Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
Official title: Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Traumatic Brain Injury
Depression
Keywords: Depression
Traumatic brain injury
Duloxetine
Cymbalta
impaired cognitive function
Lead sponsor: Rehabilitation Hospital of Indiana
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2010-10-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Hamilton Rating Scale for Depression
timeFrame: 9 months
Secondary outcomes:
measure: Hopkins Verbal Learning Test
timeFrame: 9 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
Study officials:
affiliation: Rehabilitation Hospital of Indiana
name: Lance Trexler, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: