PTSD Prevention Using Escitalopram

Sheba Medical Center5 sites in 1 country450 target enrollmentJune 2005

Overview

Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing its severeness, after exposure to a traumatic event.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

May 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Principal Investigator

Prof. Joseph Zohar

Sheba Medical Center

•The patient is able to read and understand the Patient Informed Consent.
•The patient has signed the Patient Informed Consent.
•The patient has sufficient knowledge of Hebrew in order to understand the study procedure and instruments
•The patient is male or female aged between 18 and 65 years (extremes included).
•The patient underwent a traumatic event, such as vehicle or other accident, terror attack, physical or sexual assault within the last 3 weeks, and no more than 4 weeks ago.
•The patient meets either of the following criteria:
•Full DSM-IV criteria for ASD
•Intrusion and hyperarousal criteria only

•The patient refuses having any medication therapy. This patient will be referred to another treatment outside the study frame.
•The patient has a serious physical injury at inclusion, in which his Abbreviated Injury Scale (AIS) score, for at least one of his body regions, is 3 or more, or that according to the judgment of the clinician his injury sequelae would interfere with the study treatment.
•The patient uses concomitant medications not allowed in the study:
•Antidepressants, including MAOI, RIMA within the last 3 weeks prior to screening.
•Mood stabilizers within the last 3 weeks prior to screening.
•Antipsychotic medications within the last 3 weeks prior to screening.
•Anxiolytics 2 weeks in a row before randomization. Patient can participate in the study if did not take the medications for 3 days over the two weeks before randomization. Except for oxazepam 10-20 mg/day no more than 7 days in a raw.
•Serotonergic agonists (e.g. triptans) within the last 2 weeks prior to screening.
•Prophylactic treatment with any anticonvulsant drug.
•Herbal remedies that are psychoactive (e.g. St John's Wort, Kava kava, valerian, gingko biloba) within the last 3 weeks prior to screening.