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

Sponsor

Hadassah Medical Organization (Other)

Overall Status

Completed

CT.gov ID

NCT00736021

Collaborator

(none)

Enrollment

Location

Arm

17.9

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders, Post Traumatic	Drug: Escitalopram	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Proportion of Participants completing the study [twelve weeks of active treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)