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PTSD Prevention Using Escitalopram

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Escitalopram
Placebo
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barzilai Medical Center
  • Soroka Medical Center
  • RAMBAM Medical Center
  • Hadassa Medical Center
  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

CAPS

Secondary Outcome Measures

Full Information

First Posted
March 7, 2006
Last Updated
December 30, 2013
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00300313
Brief Title
PTSD Prevention Using Escitalopram
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
10 to 20 mg / day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1-2 capsules
Primary Outcome Measure Information:
Title
CAPS
Time Frame
1-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Zohar, MD
Organizational Affiliation
Chaim Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Facility Name
Soroka Medical Center
City
Beer-Sheva
Country
Israel
Facility Name
RAMBAM Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassa Medical Center
City
Jerusalem
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat-Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
35141873
Citation
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.
Results Reference
derived
PubMed Identifier
28703951
Citation
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.
Results Reference
derived
PubMed Identifier
25885650
Citation
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.
Results Reference
derived

Learn more about this trial

PTSD Prevention Using Escitalopram

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