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

Not Applicable

Completed

• Conditions: Stress Disorders, Post Traumatic
• Interventions: Drug: Escitalopram

• Registration Number: NCT00736021
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Status Verified: 2008-09
• Study Start: 2008-09
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-21
• Last Update Posted: 2010-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Escitalopram	Single arm (open label study): Provide twelve weeks of treatment with high does (40 mg daily) of escitalopram to trauma survivors with chronic PTSD.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of Participants completing the study	twelve weeks of active treatment

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel