Official Title: “Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder”

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.

Study Type: Interventional

Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: December 2004

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Subjects were started on 5mg escitalopram. Medication was increased as tolerated in weekly 2.5, 5 or 10 mg increments, until a maximally tolerated dosage or a clinical response was achieved. The final dosage ranged from 5 to 20 mg/day.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Escitalopram
  • Flexible dose (5-20mg/day) of escitalopram monotherapy.

Primary Measures

• The Clinician Administered PTSD Scale
  • Time Frame: Administered at baseline (prior to treatment) and week 12
    Safety Issue?: No

Secondary Measures

• PTSD Checklist
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Beck Depression Inventory
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Profile of Mood State
  • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
    Safety Issue?: No
• Social Adjustment Scale
  • Time Frame: Initial, Mid-Trial and Final Assessments
    Safety Issue?: No
• Quality of Life Inventory
  • Time Frame: Initial, Mid-Trial and Final Assessments
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Northern California Institute of Research and Education

Overall Clinical Trial Officials and Contacts

Thomas C Neylan, MD Principal Investigator UCSF / VAMC / NCIRE  

Information obtained from ClinicalTrials.gov on September 02, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01024140

Study ID Number: NEY-608

ClinicalTrials.gov Identifier: NCT01024140

Health Authority: United States: Institutional Review Board