Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01368432
First received: June 3, 2011
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).


Condition Intervention Phase
TBI
Major Depression
Other Psychiatric Disorders
Drug: Escitalopram
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
    This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess for change in symptoms across the study at baseline, 4 weeks, 8 weeks, and 12 weeks.


Secondary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Daily for 12 weeks
Drug: Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
Other Name: Lexapro
Experimental: Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks
Drug: Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
Other Name: Lexapro

Detailed Description:

Despite it's high prevalence, little is known about the pharmacological treatment of depression following Traumatic Brain Injury (TBI). This is because of a lack of randomized controlled studies in the treatment of post-TBI depression. This study is designed to examine the safety and effectiveness of escitalopram in the treatment of post-TBI depression. It will also investigate metabolic changes and neural pathways associated with post-TBI depression and metabolic alterations after treatment through neuroimaging.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Closed head injury
  • Fulfill DSM IV criteria "Major Depressive Disorder"
  • 18 years of age or older
  • Able to provide informed consent
  • Stable medical history

Exclusion Criteria:

  • History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
  • History of mental retardation
  • Alcohol or Substance dependence in the last 1 year
  • Inability to undergo MRI scan
  • Pregnancy
  • Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics
  • Poor response to escitalopram in the past
  • Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist
  • Good medication response to another antidepressant in the past
  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: NCT01368432

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Forest Laboratories
Investigators
Principal Investigator: Vani Rao, M.D Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Vani Rao, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01368432     History of Changes
Other Study ID Numbers: NA_00020154
Study First Received: June 3, 2011
Last Updated: September 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
TBI
Depression
Mood
Behavior

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014