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

Phase 2

Completed

• Conditions: TBI; Major Depression; Other Psychiatric Disorders
• Interventions: Drug: Placebo; Drug: Escitalopram

• Registration Number: NCT01368432
• Lead Sponsor: Johns Hopkins University

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 Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Primary Completion: 2012-12
• Study Completion: 2013-03
• Results First Submitted: 2016-07-13
• Status Verified: 2016-08
• Results First Submitted QC: 2016-08-31
• Last Update Submitted: 2016-08-31
• Results First Posted: 2016-10-24
• Last Update Posted: 2016-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Daily for 12 weeks
Escitalopram	Escitalopram	Escitalopram 10 mg or 20 mg daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline	MADRS score at baseline	This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.; 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression.; In this study the score was used as a continuous variable.
Montgomery-Asberg Depression Rating Scale (MADRS)	MADRS score at 12 weeks	This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.; 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression.; In this study the score was used as a continuous variable.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression (CGI) - Severity at Baseline	Baseline	This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7; 1. = Normal-not at all ill; 2. = Borderline mentally ill; 3. = Mildly ill; 4. = Moderately ill; 5. = Markedly ill; 6. = Severely ill; 7. = Among the most extremely ill patients.
Satisfaction With Life (SWL)	12 weeks	This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.; The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).; It is used as continuous variable.
Clinical Global Impression (CGI)- Improvement	at 12 weeks	This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.; The scores range from 1-7; 1. = Very much improved; 2. = Much improved; 3. = Minimally improved; 4. = No change; 5. = Minimally worse; 6. = Much worse; 7. = Very much worse
Clinical Anxiety Scale (CAS)	12 weeks	This outcome measure is assessing the participant's anxiety as assessed by the CAS.; The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable.
Quality of Life (QWL)	At 12 weeks	This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.; Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable.
Disability Rating Scale (DRS)	At 12 weeks	This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.; Scores range from 0 (normal) and 29 (extreme vegetative state).
Mini Mental Status Exam (MMSE)	At 12 weeks	This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).; A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States