PTSD Prevention Using Escitalopram

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Joseph Zohar, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00300313
First received: March 7, 2006
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Post-traumatic Stress Disorder
Drug: Escitalopram
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • CAPS [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: June 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Escitalopram
10 to 20 mg / day
Placebo Comparator: 2 Drug: Placebo
1-2 capsules

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300313

Locations
Israel
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
Investigators
Study Director: Joseph Zohar, MD Chaim Sheba Medical Center
  More Information

No publications provided

Responsible Party: Prof. Joseph Zohar, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00300313     History of Changes
Other Study ID Numbers: SHEBA-06-3913-JZ-CTIL
Study First Received: March 7, 2006
Last Updated: December 30, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 23, 2014