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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Johns Hopkins University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Forest Laboratories

Information provided by:

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01368432

First received: June 3, 2011

Last updated: June 7, 2011

Last verified: February 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

June 3, 2011

Last Updated Date

June 7, 2011

Start Date ^ICMJE

April 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01368432 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clinical Global Impression (CGI) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

TBI
Major Depression
Other Psychiatric Disorders

Intervention ^ICMJE

Drug: Escitalopram

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

Other Name: Lexapro

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Alyssa Bergey, M.A.

410-550-9022

abergey1@jhmi.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01368432

Other Study ID Numbers ^ICMJE

NA_00020154

Has Data Monitoring Committee

Yes

Responsible Party

Vani Rao, M.D., Johns Hopkins University

Study Sponsor ^ICMJE

Johns Hopkins University

Collaborators ^ICMJE

Forest Laboratories

Investigators ^ICMJE

Principal Investigator:

Vani Rao, M.D

Johns Hopkins University

Information Provided By

Johns Hopkins University

Verification Date

February 2009

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

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