Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury - Full Text View

Purpose

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.

Condition	Intervention	Phase
Traumatic Brain Injury Depression	Drug: Duloxetine Drug: Sugar pill	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine

Resource links provided by NLM:

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Rehabilitation Hospital of Indiana:

Primary Outcome Measures:

Hamilton Rating Scale for Depression [ Time Frame: 9 months ] [ Designated as safety issue: No ]
To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.

Secondary Outcome Measures:

Hopkins Verbal Learning Test [ Time Frame: 9 months ] [ Designated as safety issue: No ]
To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.


Enrollment:	8
Study Start Date:	September 1996
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Duloxetine 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.	Drug: Duloxetine 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. Other Name: Cymbalta
Placebo Comparator: Sugar pill 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.	Drug: Sugar pill 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. Other Name: Lactose

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


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01223001

Locations


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

Sponsors and Collaborators

Rehabilitation Hospital of Indiana

Eli Lilly and Company

Investigators


Principal Investigator:	Lance Trexler, Ph.D.	Rehabilitation Hospital of Indiana

More Information


Responsible Party:	Rehabilitation Hospital of Indiana
ClinicalTrials.gov Identifier:	NCT01223001 History of Changes
Other Study ID Numbers:	RHI 05-096 F1J-US-X025
Study First Received:	October 15, 2010
Results First Received:	November 6, 2014
Last Updated:	December 15, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Rehabilitation Hospital of Indiana:


Depression Traumatic brain injury Duloxetine Cymbalta impaired cognitive function

Additional relevant MeSH terms:


Wounds and Injuries Brain Injuries Brain Diseases Craniocerebral Trauma Trauma, Nervous System Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Central Nervous System Diseases Nervous System Diseases Duloxetine Hydrochloride	Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents

ClinicalTrials.gov processed this record on September 26, 2016

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