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Trial record 1 of 1 for:    NCT00300313
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PTSD Prevention Using Escitalopram

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ClinicalTrials.gov Identifier: NCT00300313
Recruitment Status : Completed
First Posted : March 8, 2006
Last Update Posted : December 31, 2013
Information provided by (Responsible Party):
Prof. Joseph Zohar, Sheba Medical Center

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

Condition or disease Intervention/treatment Phase
Post-traumatic Stress Disorder Drug: Escitalopram Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Study Start Date : June 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Escitalopram
10 to 20 mg / day

Placebo Comparator: 2 Drug: Placebo
1-2 capsules

Primary Outcome Measures :
  1. CAPS [ Time Frame: 1-year follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient is able to read and understand the Patient Informed Consent.
  2. The patient has signed the Patient Informed Consent.
  3. The patient has sufficient knowledge of Hebrew in order to understand the study procedure and instruments
  4. The patient is male or female aged between 18 and 65 years (extremes included).
  5. 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.
  6. The patient meets either of the following criteria:

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

Exclusion Criteria:

  1. The patient refuses having any medication therapy. This patient will be referred to another treatment outside the study frame.
  2. 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.
  3. The patient uses concomitant medications not allowed in the study:

    1. Antidepressants, including MAOI, RIMA within the last 3 weeks prior to screening.
    2. Mood stabilizers within the last 3 weeks prior to screening.
    3. Antipsychotic medications within the last 3 weeks prior to screening.
    4. 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.
    5. Serotonergic agonists (e.g. triptans) within the last 2 weeks prior to screening.
    6. Prophylactic treatment with any anticonvulsant drug.
    7. Herbal remedies that are psychoactive (e.g. St John's Wort, Kava kava, valerian, gingko biloba) within the last 3 weeks prior to screening.
  4. The patient meets lifetime DSM-IV-TR criteria for:

    1. Mania or Bipolar disorder
    2. Schizophrenia
    3. Any personality disorder judged by the investigator to jeopardize the evaluation of the treatment.
    4. Mental retardation or pervasive disorder
    5. Cognitive disorder (inc. dementia)
  5. The patient has or has had alcohol or drug abuse related disorders in the last year prior to the screening visit.
  6. The patient has, in the investigator's opinion, significant suicide risk and/or a score of ≥ 5 on question 10 in the MADRS scale.
  7. The patient has a history of severe suicide attempt.
  8. The patient requires ElectroConvulsive Therapy (ECT) or has received ECT within the last year prior to the screening visit.
  9. The patient is currently serving in the Israeli security forces.
  10. The patient has a history of drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or citalopram.
  11. 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
  12. The patient is pregnant or breast-feeding.
  13. 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).
  14. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol.
  15. The patient has previously participated in the current study or in any other study within the last 30 days.
  16. The patient has familial relationships with the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300313

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Barzilai Medical Center
Ashkelon, Israel
Soroka Medical Center
Beer-Sheva, Israel
RAMBAM Medical Center
Haifa, Israel
Hadassa Medical Center
Jerusalem, Israel
Chaim Sheba Medical Center
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
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Study Director: Joseph Zohar, MD Chaim Sheba Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Joseph Zohar, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00300313    
Other Study ID Numbers: SHEBA-06-3913-JZ-CTIL
First Posted: March 8, 2006    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
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