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

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	Not Applicable

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 (Clinical Trial)
• 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: September 2008
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 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 Name: Lexapro, Cipralex

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Proportion of Participants completing the study [ Time Frame: twelve weeks of active treatment ]

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

Israel

Hadassah University Hospital

Jerusalem, Israel, 91120

Sponsors and Collaborators

Hadassah Medical Organization

Investigators

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

More Information

• Responsible Party: Arieh Y. Shalev, M.D., Department of Psychiatry, Hadassah University Hospital, Jerusalem, Israel
• ClinicalTrials.gov Identifier: NCT00736021
• Other Study ID Numbers: HMO_SHALEV_02
• First Posted: August 15, 2008
• Last Update Posted: March 23, 2010
• Last Verified: September 2008

Keywords provided by Hadassah Medical Organization:

PTSD; Pharmacological Treatment; SSRI; Escitalopram; Anxiety Disorders

Additional relevant MeSH terms:

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs