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

Rehabilitation Hospital of Indiana

Status and phase: Terminated; Phase 2

Conditions: Traumatic Brain Injury; Depression

Treatments: Drug: Duloxetine; Drug: Sugar pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01223001

F1J-US-X025 (Other Identifier)

RHI 05-096

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Duloxetine

Active Comparator group

Description:

Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.

Treatment:

Drug: Duloxetine

Sugar pill

Placebo Comparator group

Description:

Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.

Treatment:

Drug: Sugar pill