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