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

March 21, 2010 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
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
Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily
Other Names:
  • Lexapro, Cipralex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants completing the study
Time Frame: twelve weeks of active treatment
twelve weeks of active treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Areh Y SHALEV, M.D., Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

March 1, 2010

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (ESTIMATE)

August 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 23, 2010

Last Update Submitted That Met QC Criteria

March 21, 2010

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMO_SHALEV_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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