Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Information source: Northern California Institute of Research and Education
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Posttraumatic Stress Disorder
Intervention: Escitalopram (Drug)
Phase: N/A
Status: Completed
Sponsored by: Northern California Institute of Research and Education Official(s) and/or principal investigator(s): Thomas C Neylan, MD, Principal Investigator, Affiliation: UCSF / VAMC / NCIRE
Summary
The primary aim of this pilot study is to test the efficacy of the selective serotonin
re-uptake inhibitor, Escitalopram, in the treatment of posttraumatic stress disorder (PTSD)
in an open clinical trial.
A secondary aim is to determine whether treatment with escitalopram increases plasma
allopregnanolone levels in patients with PTSD and if increases in allopregnanolone levels
are correlated with treatment efficacy.
Clinical Details
Official title: Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The Clinician Administered PTSD Scale
Secondary outcome: PTSD ChecklistBeck Depression Inventory Profile of Mood State Social Adjustment Scale Quality of Life Inventory
Eligibility
Minimum age: 20 Years.
Maximum age: 60 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Current DSM-IV TR PTSD and a score > 40 on the CAPS, as a result of a traumatic event
that occurred at least 6 months prior to evaluation.
Exclusion Criteria:
- Lifetime history of bipolar or any psychiatric disorder with psychotic features.
- Prominent suicidal or homicidal ideation.
- History of alcohol abuse/dependence within the past 3 months.
- History of drug abuse/dependence within the past 6 months.
- Subjects who plan to start a new form of psychotherapy during the protocol.
- History of sleep apnea, neurological disorder and/or current systemic illness
affecting central nervous system function.
- History of myocardial infarction in the past year.
- Subjects on antipsychotic medications, systemic steroid medication, antidepressants,
mood stabilizers, antianxiety medication, or benzodiazepines within the past 2 weeks.
- Use of Citalopram or Escitalopram within the past 6 months.
Locations and Contacts
Additional Information
Starting date: February 2003
Last updated: December 1, 2009
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