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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-03-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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TBI Major Depression Other Psychiatric Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill placebo

Escitalopram

Escitalopram 10 mg or 20 mg daily for 12 weeks

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth

Interventions

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Escitalopram

Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth

Intervention Type DRUG

Placebo

Sugar pill placebo

Intervention Type DRUG

Other Intervention Names

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Lexapro sugar pill

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No