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).

Study Overview

• Status: Completed
• Conditions: Major Depression; TBI; Other Psychiatric Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Escitalopram

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: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Daily for 12 weeks	Drug: Placebo; Sugar pill placebo; Other Names: sugar pill
Experimental: Escitalopram; Escitalopram 10 mg or 20 mg daily for 12 weeks	Drug: Escitalopram; Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth; Other Names: Lexapro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS) 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.	MADRS score at baseline
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 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.	MADRS score at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression (CGI) - Severity at 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; = Normal-not at all ill; = Borderline mentally ill; = Mildly ill; = Moderately ill; = Markedly ill; = Severely ill; = Among the most extremely ill patients.	Baseline
Clinical Global Impression (CGI)- Improvement	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; = Very much improved; = Much improved; = Minimally improved; = No change; = Minimally worse; = Much worse; = Very much worse	at 12 weeks
Clinical Anxiety Scale (CAS)	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.	Baseline
Clinical Anxiety Scale (CAS)	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.	12 weeks
Satisfaction With Life (SWL)	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.	baseline
Satisfaction With Life (SWL)	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.	12 weeks
Quality of Life (QWL)	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.	At baseline
Quality of Life (QWL)	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.	At 12 weeks
Disability Rating Scale (DRS)	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).	At baseline
Disability Rating Scale (DRS)	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).	At 12 weeks
Mini Mental Status Exam (MMSE)	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.	At baseline
Mini Mental Status Exam (MMSE)	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.	At 12 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Forest Laboratories
• Investigators: Principal Investigator: Vani Rao, M.D, Johns Hopkins University

Publications and helpful links

Helpful Links

• Brain Injury Association of Maryland

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: June 3, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 2011

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: August 31, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Depression; Behavior; TBI; Mood
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Problem Behavior; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: NA_00020154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO