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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: TBI; Major Depression; Other Psychiatric Disorders

Intervention: Escitalopram (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Vani Rao, M.D, Principal Investigator, Affiliation: Johns Hopkins University


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).

Clinical Details

Official title: Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome: Clinical Global Impression (CGI)

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Johns Hopkins University, Baltimore, Maryland 21224, United States
Additional Information

Brain Injury Association of Maryland

Starting date: April 2010
Last updated: September 19, 2013

Page last updated: August 23, 2015

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