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Completed

NCT Number: NCT01368432

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

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).

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Key information

Conditions

TBI Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders Other Psychiatric Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth

Other names: Lexapro

Placebo

Drug

Sugar pill placebo

Other names: sugar pill

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

    • = Normal-not at all ill
    • = Borderline mentally ill
    • = Mildly ill
    • = Moderately ill
    • = Markedly ill
    • = Severely ill
    • = Among the most extremely ill patients.

  2. 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

    • = Very much improved
    • = Much improved
    • = Minimally improved
    • = No change
    • = Minimally worse
    • = Much worse
    • = Very much worse

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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).

  10. 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).

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jun 8, 2011
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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