Lexapro for the Treatment of Traumatic Brain Injury (TBI) Depression & Other Psychiatric Conditions
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Johns Hopkins University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johns Hopkins University
Collaborator:
Forest Laboratories
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01368432
First received: June 3, 2011
Last updated: June 7, 2011
Last verified: February 2009
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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 |
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) [ Time Frame: baseline, 4 weeks, 8 weeks, 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 for change in symptoms across the study at baseline, 4 weeks, 8 weeks, and 12 weeks.
Secondary Outcome Measures:
- Clinical Global Impression (CGI) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Daily for 12 weeks
|
Drug: Escitalopram
Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
Other Name: Lexapro
|
|
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Closed head injury
- Fulfill 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368432
Contacts
| Contact: Alyssa Bergey, M.A. | 410-550-9022 | abergey1@jhmi.edu |
Locations
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21224 | |
| Contact: Alyssa Bergey, M.A. 410-550-9022 abergey1@jhmi.edu | |
| Principal Investigator: Vani Rao, M.D. | |
Sponsors and Collaborators
Johns Hopkins University
Forest Laboratories
Investigators
| Principal Investigator: | Vani Rao, M.D | Johns Hopkins University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Vani Rao, M.D., Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01368432 History of Changes |
| Other Study ID Numbers: | NA_00020154 |
| Study First Received: | June 3, 2011 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
TBI Depression Mood Behavior |
Additional relevant MeSH terms:
|
Mental Disorders Depression Depressive Disorder Depressive Disorder, Major Brain Injuries Behavioral Symptoms Mood Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Dexetimide Citalopram |
Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on June 18, 2013