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

Northern California Institute of Research and Education16 enrolled

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Posttraumatic Stress Disorder

Interventions

EscitalopramDRUG

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.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The Clinician Administered PTSD Scale

Time frame: Administered at baseline (prior to treatment) and week 12

Secondary Outcomes

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

Data from ClinicalTrials.gov

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