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Trial record 47 of 589 for:    ESCITALOPRAM AND Celexa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE June 3, 2011
First Posted Date  ICMJE June 8, 2011
Results First Submitted Date  ICMJE July 13, 2016
Results First Posted Date  ICMJE October 24, 2016
Last Update Posted Date October 24, 2016
Study Start Date  ICMJE April 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • TBI
  • Major Depression
  • Other Psychiatric Disorders
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2016)
16
Original Estimated Enrollment  ICMJE
 (submitted: June 7, 2011)
45
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01368432
Other Study ID Numbers  ICMJE NA_00020154
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vani Rao, MD, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Vani Rao, M.D Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP