PTSD Prevention Using Escitalopram

NCT00300313 | Completed

• 1 other identifier: SHEBA-06-3913-JZ-CTIL
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Post-traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• CAPS

  1-year follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Escitalopram

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Escitalopram DRUG

10 to 20 mg / day

1

Placebo DRUG

1-2 capsules

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• The patient refuses having any medication therapy. This patient will be referred to another treatment outside the study frame.
• 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)

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (5)

Barzilai Medical Center

Ashkelon, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

RAMBAM Medical Center

Haifa, Israel

Location

Hadassa Medical Center

Jerusalem, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, Israel

Location

Related Publications (4)

• Bertolini F, Robertson L, Bisson JI, Meader N, Churchill R, Ostuzzi G, Stein DJ, Williams T, Barbui C. Early pharmacological interventions for prevention of post-traumatic stress disorder (PTSD) in individuals experiencing acute traumatic stress symptoms. Cochrane Database Syst Rev. 2024 May 20;5(5):CD013613. doi: 10.1002/14651858.CD013613.pub2.

  PMID: 38767196 DERIVED

• 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.

  PMID: 35141873 DERIVED

• 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.

  PMID: 28703951 DERIVED

• 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.

  PMID: 25885650 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Joseph Zohar, MD

  Chaim Sheba Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Joseph Zohar

Study Record Dates

• First Submitted: March 7, 2006
• First Posted: March 8, 2006
• Study Start: June 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

IL (5)