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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00736021
First received: August 14, 2008
Last updated: March 21, 2010
Last verified: September 2008
  Purpose

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 Intervention
Stress Disorders, Post Traumatic
Drug: Escitalopram

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of Participants completing the study [ Time Frame: twelve weeks of active treatment ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736021

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

No publications provided

Responsible Party: Arieh Y. Shalev, M.D., Department of Psychiatry, Hadassah University Hospital, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00736021     History of Changes
Other Study ID Numbers: HMO_SHALEV_02
Study First Received: August 14, 2008
Last Updated: March 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
PTSD
Pharmacological Treatment
SSRI
Escitalopram
Anxiety Disorders

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014