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

Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stress Disorders, Post Traumatic

Intervention: Escitalopram (Drug)

Phase: N/A

Status: Completed

Sponsored by: Hadassah Medical Organization

Official(s) and/or principal investigator(s):
Areh Y SHALEV, M.D., Principal Investigator, Affiliation: Hadassah Medical Organization

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome: Proportion of Participants completing the study

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

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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)

Locations and Contacts

Hadassah University Hospital, Jerusalem 91120, Israel
Additional Information

Starting date: September 2008
Last updated: March 21, 2010

Page last updated: August 23, 2015

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