- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00300313
PTSD Prevention Using Escitalopram
December 30, 2013 updated by: Prof. Joseph Zohar, Sheba Medical Center
Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing its severeness, after exposure to a traumatic event.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
450
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Ashkelon, Israel
- Barzilai Medical Center
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Beer-Sheva, Israel
- Soroka Medical Center
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Haifa, Israel
- Rambam Medical Center
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Jerusalem, Israel
- Hadassa Medical Center
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Ramat-Gan, Israel
- Chaim Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
1-2 capsules
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Active Comparator: 1
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10 to 20 mg / day
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CAPS
Time Frame: 1-year follow-up
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1-year follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Joseph Zohar, MD, Chaim Sheba Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for universal prevention of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2022 Feb 10;2(2):CD013443. doi: 10.1002/14651858.CD013443.pub2.
- Zohar J, Fostick L, Juven-Wetzler A, Kaplan Z, Shalev H, Schreiber G, Miroshnik N, Shalev AY, Stein DJ, Seedat S, Suliman S, Klein E. Secondary Prevention of Chronic PTSD by Early and Short-Term Administration of Escitalopram: A Prospective Randomized, Placebo-Controlled, Double-Blind Trial. J Clin Psychiatry. 2018 Mar/Apr;79(2):16m10730. doi: 10.4088/JCP.16m10730.
- Suliman S, Seedat S, Pingo J, Sutherland T, Zohar J, Stein DJ. Escitalopram in the prevention of posttraumatic stress disorder: a pilot randomized controlled trial. BMC Psychiatry. 2015 Feb 19;15:24. doi: 10.1186/s12888-015-0391-3.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
March 7, 2006
First Submitted That Met QC Criteria
March 7, 2006
First Posted (Estimate)
March 8, 2006
Study Record Updates
Last Update Posted (Estimate)
December 31, 2013
Last Update Submitted That Met QC Criteria
December 30, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- SHEBA-06-3913-JZ-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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