Phase 2
N=14
Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
TBI · Major Depression · Other Psychiatric Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01368432 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline — 29.5; 33.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Escitalopram (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline |
29.5; 33.6 | — |
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) |
11.2; 7 | — |
| SECONDARY Clinical Global Impression (CGI) - Severity at Baseline |
4.5; 4.8 | — |
| SECONDARY Clinical Global Impression (CGI)- Improvement |
2.7; 2.1 | — |
| SECONDARY Clinical Anxiety Scale (CAS) |
6.3; 3.9 | — |
| SECONDARY Clinical Anxiety Scale (CAS) |
6.3; 3.9 | — |
| SECONDARY Satisfaction With Life (SWL) |
21.2; 22.6 | — |
| SECONDARY Satisfaction With Life (SWL) |
21.2; 22.6 | — |
| SECONDARY Quality of Life (QWL) |
75.2; 78.7 | — |
| SECONDARY Quality of Life (QWL) |
75.2; 78.7 | — |
| SECONDARY Disability Rating Scale (DRS) |
0.7; 0.6 | — |
| SECONDARY Disability Rating Scale (DRS) |
0.7; 0.6 | — |
| SECONDARY Mini Mental Status Exam (MMSE) |
29.7; 29.0 | — |
| SECONDARY Mini Mental Status Exam (MMSE) |
29.7; 29.0 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01368432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.