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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Vani Rao, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01368432
First received: June 3, 2011
Last updated: August 31, 2016
Last verified: August 2016
  Purpose
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).

Condition Intervention Phase
TBI
Major Depression
Other Psychiatric Disorders
Drug: Escitalopram
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline [ Time Frame: MADRS score at baseline ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 16
Study Start Date: April 2010
Study Completion Date: March 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Daily for 12 weeks
Drug: Placebo
Sugar pill placebo
Other Name: 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 Name: Lexapro

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368432

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Forest Laboratories
Investigators
Principal Investigator: Vani Rao, M.D Johns Hopkins University
  More Information

Additional Information:
Responsible Party: Vani Rao, MD, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01368432     History of Changes
Other Study ID Numbers: NA_00020154 
Study First Received: June 3, 2011
Results First Received: July 13, 2016
Last Updated: August 31, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Johns Hopkins University:
TBI
Depression
Mood
Behavior

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Problem Behavior
Behavioral Symptoms
Mood Disorders
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on December 08, 2016