Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram

Study Overview
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Brief Summary
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The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic events. Forty survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks. The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward). The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

Detailed Description
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The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) Forty adult survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks. The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward). The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

Official Title
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Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD

Conditions
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Stress Disorders, Post Traumatic

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult survivors of traumatic events with chronic PTSD Exclusion Criteria: Individuals with past history of psychotic disorder, bipolar disorder, opiate or stimulants abuse. Individuals currently on anti-depressant therapy. Individuals with past history of a failure to respond to escitalopram Pregnant Women Medical condition excluding the treatment with escitalopram (e.g., renal or hepatic insufficiency). Current, life threatening medical illness. History or severe side effects with escitalopram (e.g., hyponatremia)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Single arm (open label study): Provide twelve weeks of treatment with high does (40 mg daily) of escitalopram to trauma survivors with chronic PTSD. | Drug: Escitalopram<br>* Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily<br>* Other names: Lexapro, Cipralex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS) |  | Twelve Weeks on Active Medication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants completing the study |  | twelve weeks of active treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Pharmacological Treatment, SSRI, Escitalopram, Anxiety Disorders