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

Johns Hopkins University

Status and phase

Completed

Phase 2

Conditions

Major Depression

Other Psychiatric Disorders

TBI

Treatments

Drug: Placebo

Drug: Escitalopram

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01368432

NA_00020154

Details and patient eligibility

About

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).

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Closed head injury
Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (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