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

Primary Purpose

TBI, Major Depression, Other Psychiatric Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI focused on measuring TBI, Depression, Mood, Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Escitalopram

Arm Description

Daily for 12 weeks

Escitalopram 10 mg or 20 mg daily for 12 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.

Full Information

First Posted
June 3, 2011
Last Updated
August 31, 2016
Sponsor
Johns Hopkins University
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01368432
Brief Title
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Official Title
Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI, Major Depression, Other Psychiatric Disorders
Keywords
TBI, Depression, Mood, Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Daily for 12 weeks
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram 10 mg or 20 mg daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Sugar pill placebo
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
Description
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.
Time Frame
MADRS score at baseline
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
MADRS score at 12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI) - Severity at Baseline
Description
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.
Time Frame
Baseline
Title
Clinical Global Impression (CGI)- Improvement
Description
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
Time Frame
at 12 weeks
Title
Clinical Anxiety Scale (CAS)
Description
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.
Time Frame
Baseline
Title
Clinical Anxiety Scale (CAS)
Description
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.
Time Frame
12 weeks
Title
Satisfaction With Life (SWL)
Description
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.
Time Frame
baseline
Title
Satisfaction With Life (SWL)
Description
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.
Time Frame
12 weeks
Title
Quality of Life (QWL)
Description
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.
Time Frame
At baseline
Title
Quality of Life (QWL)
Description
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.
Time Frame
At 12 weeks
Title
Disability Rating Scale (DRS)
Description
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).
Time Frame
At baseline
Title
Disability Rating Scale (DRS)
Description
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).
Time Frame
At 12 weeks
Title
Mini Mental Status Exam (MMSE)
Description
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.
Time Frame
At baseline
Title
Mini Mental Status Exam (MMSE)
Description
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.
Time Frame
At 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vani Rao, M.D
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.biamd.org
Description
Brain Injury Association of Maryland

Learn more about this trial

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

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