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

• ClinicalTrials.gov Identifier: NCT01368432
• Recruitment Status: Completed
• First Posted: June 8, 2011
• Results First Posted: October 24, 2016
• Last Update Posted: October 24, 2016
• Sponsor: Johns Hopkins University
• Collaborator: Forest Laboratories
• Information provided by (Responsible Party): Vani Rao, MD, Johns Hopkins University

Tracking Information

• First Submitted Date: June 3, 2011
• First Posted Date: June 8, 2011
• Results First Submitted Date: July 13, 2016
• Results First Posted Date: October 24, 2016
• Last Update Posted Date: October 24, 2016
• Study Start Date: April 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2016)

• Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline [ Time Frame: 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) [ Time Frame: 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.

Original Primary Outcome Measures (submitted: June 7, 2011)

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]

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.

• Change History: Complete list of historical versions of study NCT01368432 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 31, 2016)

• Clinical Global Impression (CGI) - Severity at Baseline [ Time Frame: 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.
• Clinical Global Impression (CGI)- Improvement [ Time Frame: 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) [ Time Frame: Baseline ]
  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) [ Time Frame: 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.
• Satisfaction With Life (SWL) [ Time Frame: baseline ]
  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) [ Time Frame: 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.
• Quality of Life (QWL) [ Time Frame: At baseline ]
  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) [ Time Frame: 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) [ Time Frame: At baseline ]
  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) [ Time Frame: 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) [ Time Frame: At baseline ]
  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) [ Time Frame: 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.

• Original Secondary Outcome Measures (submitted: June 7, 2011): Clinical Global Impression (CGI) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• TBI
• Major Depression
• Other Psychiatric Disorders

Intervention

• Drug: Escitalopram
  Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
  Other Name: Lexapro
• Drug: Placebo
  Sugar pill placebo
  Other Name: sugar pill

Study Arms

• Placebo Comparator: Placebo
  Daily for 12 weeks
  Intervention: Drug: Placebo
• Experimental: Escitalopram
  Escitalopram 10 mg or 20 mg daily for 12 weeks
  Intervention: Drug: Escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2016): 16
• Original Estimated Enrollment (submitted: June 7, 2011): 45
• Actual Study Completion Date: March 2013
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01368432
• Other Study ID Numbers: NA_00020154
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vani Rao, MD, Johns Hopkins University
• Study Sponsor: Johns Hopkins University
• Collaborators: Forest Laboratories

Investigators

• Principal Investigator: Vani Rao, M.D; Johns Hopkins University

• PRS Account: Johns Hopkins University
• Verification Date: August 2016