Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2004

Interventions

  • 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

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

Clinical Trial Outcome Measures

Primary Measures

  • The Clinician Administered PTSD Scale
    • Time Frame: Administered at baseline (prior to treatment) and week 12

Secondary Measures

  • PTSD Checklist
    • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
  • Beck Depression Inventory
    • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
  • Profile of Mood State
    • Time Frame: Each Visit: Week 0, 2, 4, 6, 8, & 12
  • Social Adjustment Scale
    • Time Frame: Initial, Mid-Trial and Final Assessments
  • Quality of Life Inventory
    • Time Frame: Initial, Mid-Trial and Final Assessments

Participating in This Clinical Trial

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: Male

Minimum Age: 20 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northern California Institute of Research and Education
  • Provider of Information About this Clinical Study
    • Thomas C. Neylan, M.D., UCSF / VAMC / NCIRE
  • Overall Official(s)
    • Thomas C Neylan, MD, Principal Investigator, UCSF / VAMC / NCIRE

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