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Status:

COMPLETED

PTSD Prevention Using Escitalopram

Lead Sponsor:

Sheba Medical Center

Conditions:

Post-traumatic Stress Disorder

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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:
  • 1\. Full DSM-IV criteria for ASD 2. Intrusion and hyperarousal criteria only

Exclusion

  • 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.
  • The patient meets lifetime DSM-IV-TR criteria for:
  • Mania or Bipolar disorder
  • Schizophrenia
  • Any personality disorder judged by the investigator to jeopardize the evaluation of the treatment.
  • Mental retardation or pervasive disorder
  • Cognitive disorder (inc. dementia)
  • The patient has or has had alcohol or drug abuse related disorders in the last year prior to the screening visit.
  • The patient has, in the investigator's opinion, significant suicide risk and/or a score of ≥ 5 on question 10 in the MADRS scale.
  • The patient has a history of severe suicide attempt.
  • The patient requires ElectroConvulsive Therapy (ECT) or has received ECT within the last year prior to the screening visit.
  • The patient is currently serving in the Israeli security forces.
  • The patient has a history of drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or citalopram.
  • The patient has an illness and/or serious sequelae thereof, severe enough according to the clinician judgment, to prevent his participation in the study, including liver or renal insufficiency; cardiovascular, pulmonary, gastrointestinal, endocrine (inc. uncontrolled thyroid), neurological (inc. epilepsy), infectious, neoplastic, or metabolic disturbances
  • The patient is pregnant or breast-feeding.
  • The patient, if woman of childbearing potential, is not using adequate contraception (adequate contraception is defined as sexual abstinence, oral/systemic contraception, surgical sterilisation, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide).
  • The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol.
  • The patient has previously participated in the current study or in any other study within the last 30 days.
  • The patient has familial relationships with the investigator.

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

May 1 2009

Estimated Enrollment :

450 Patients enrolled

Trial Details

Trial ID

NCT00300313

Start Date

June 1 2005

End Date

May 1 2009

Last Update

December 31 2013

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Barzilai Medical Center

Ashkelon, Israel

2

Soroka Medical Center

Beersheba, Israel

3

RAMBAM Medical Center

Haifa, Israel

4

Hadassa Medical Center

Jerusalem, Israel