Clinical trial NCT01368432: Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Official title: Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: TBI
Major Depression
Other Psychiatric Disorders
Keywords: TBI
Depression
Mood
Behavior
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
First posted: 2011-06-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
timeFrame: MADRS score at baseline
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: MADRS score at 12 weeks
Secondary outcomes:
measure: Clinical Global Impression (CGI) - Severity at Baseline
timeFrame: Baseline
measure: Clinical Global Impression (CGI)- Improvement
timeFrame: at 12 weeks
measure: Clinical Anxiety Scale (CAS)
timeFrame: Baseline
measure: Clinical Anxiety Scale (CAS)
timeFrame: 12 weeks
measure: Satisfaction With Life (SWL)
timeFrame: baseline
measure: Satisfaction With Life (SWL)
timeFrame: 12 weeks
measure: Quality of Life (QWL)
timeFrame: At baseline
measure: Quality of Life (QWL)
timeFrame: At 12 weeks
measure: Disability Rating Scale (DRS)
timeFrame: At baseline
measure: Disability Rating Scale (DRS)
timeFrame: At 12 weeks
measure: Mini Mental Status Exam (MMSE)
timeFrame: At baseline
measure: Mini Mental Status Exam (MMSE)
timeFrame: At 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Vani Rao, M.D
role: PRINCIPAL_INVESTIGATOR
References: