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

Major Depression Clinical Trial

Official title:

Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368432
• Other study ID #: NA_00020154
• Status: Completed
• Phase: Phase 2
• First received: June 3, 2011
• Last updated: September 19, 2013
• Start date: April 2010
• Est. completion date: March 2013

Study information

• Verified date: September 2013
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Mental Disorders
• Other Psychiatric Disorders
• TBI

Intervention

Drug:
• Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	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.	baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Clinical Global Impression (CGI)		baseline, 4 weeks, 8 weeks, 12 weeks	No

External Links

•   Brain Injury Association of Maryland