Official Title: “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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: September 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Escitalopram
  • Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Treatment with up to 40 mg escitalopram daily for twelve weeks

Primary Measures

• Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)
  • Time Frame: Twelve Weeks on Active Medication
    Safety Issue?: No

Secondary Measures

• Proportion of Participants completing the study
  • Time Frame: twelve weeks of active treatment
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hadassah Medical Organization

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00736021

Study ID Number: HMO_SHALEV_02

ClinicalTrials.gov Identifier: NCT00736021

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration