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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 Checklist

Beck 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

Page last updated: August 23, 2015

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