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

• ClinicalTrials.gov Identifier: NCT00736021
• Recruitment Status: Completed
• First Posted: August 15, 2008
• Last Update Posted: March 23, 2010
• Sponsor: Hadassah Medical Organization
• Information provided by: Hadassah Medical Organization

Tracking Information

• First Submitted Date: August 14, 2008
• First Posted Date: August 15, 2008
• Last Update Posted Date: March 23, 2010
• Study Start Date: September 2008
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 14, 2008): Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS) [ Time Frame: Twelve Weeks on Active Medication ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 14, 2008): Proportion of Participants completing the study [ Time Frame: twelve weeks of active treatment ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Stress Disorders, Post Traumatic

Intervention

Drug: Escitalopram

Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily

Other Name: Lexapro, Cipralex

Study Arms

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.

Intervention: Drug: Escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2010): 38
• Original Estimated Enrollment (submitted: August 14, 2008): 40
• Actual Study Completion Date: March 2010
• Actual Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00736021
• Other Study ID Numbers: HMO_SHALEV_02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Arieh Y. Shalev, M.D., Department of Psychiatry, Hadassah University Hospital, Jerusalem, Israel
• Study Sponsor: Hadassah Medical Organization
• Collaborators: Not Provided

Investigators

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

• PRS Account: Hadassah Medical Organization
• Verification Date: September 2008