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

Primary Purpose

Stress Disorders, Post Traumatic

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post Traumatic focused on measuring PTSD, Pharmacological Treatment, SSRI, Escitalopram, Anxiety Disorders

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Hadassah University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A

Arm Description

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

Outcomes

Primary Outcome Measures

Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Proportion of Participants completing the study

Full Information

First Posted
August 14, 2008
Last Updated
March 21, 2010
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00736021
Brief Title
Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram
Official Title
Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post Traumatic
Keywords
PTSD, Pharmacological Treatment, SSRI, Escitalopram, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Single arm (open label study): Provide twelve weeks of treatment with high does (40 mg daily) of escitalopram to trauma survivors with chronic PTSD.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro, Cipralex
Intervention Description
Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily
Primary Outcome Measure Information:
Title
Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)
Time Frame
Twelve Weeks on Active Medication
Secondary Outcome Measure Information:
Title
Proportion of Participants completing the study
Time Frame
twelve weeks of active treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areh Y SHALEV, M.D.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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

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