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

This study has been terminated.
(Most potential subjects had already been prescribed Cymbalta.)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Rehabilitation Hospital of Indiana
ClinicalTrials.gov Identifier:
NCT01223001
First received: October 15, 2010
Last updated: May 23, 2013
Last verified: May 2013
  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:


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 TBI, 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 TBI, 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
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

No publications provided

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
Last Updated: May 23, 2013
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:
Brain Injuries
Wounds and 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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014