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

Study Overview
=================
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.

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

Conditions
-----------------
TBI, Major Depression, Other Psychiatric Disorders

Intervention / Treatment
-----------------
* Drug: Escitalopram
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Daily for 12 weeks | Drug: Placebo<br>* Sugar pill placebo<br>* Other names: sugar pill;|
| Experimental: Escitalopram<br>Escitalopram 10 mg or 20 mg daily for 12 weeks | Drug: Escitalopram<br>* Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TBI, Depression, Mood, Behavior