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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01368432
First received: June 3, 2011
Last updated: September 19, 2013
Last verified: September 2013

June 3, 2011
September 19, 2013
April 2010
December 2012   (final data collection date for primary outcome measure)
Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess for change in symptoms across the study at baseline, 4 weeks, 8 weeks, and 12 weeks.
Same as current
Complete list of historical versions of study NCT01368432 on ClinicalTrials.gov Archive Site
Clinical Global Impression (CGI) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • TBI
  • Major Depression
  • Other Psychiatric Disorders
Drug: Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
Other Name: Lexapro
  • Placebo Comparator: Placebo
    Daily for 12 weeks
    Intervention: Drug: Escitalopram
  • Experimental: Escitalopram
    Escitalopram 10 mg or 20 mg daily for 12 weeks
    Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01368432
NA_00020154
Yes
Vani Rao, MD, Johns Hopkins University
Johns Hopkins University
Forest Laboratories
Principal Investigator: Vani Rao, M.D Johns Hopkins University
Johns Hopkins University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP