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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>Flexible dose (5-20mg/day) of escitalopram monotherapy. | Drug: Escitalopram<br>* 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.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Clinician Administered PTSD Scale |  | Administered at baseline (prior to treatment) and week 12 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Escitalopram, Efficacy