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Assessing the efficacy of escitalopram in preventing the development of PTSD, or or reducing its severeness, after exposure to a traumatic event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10 to 20 mg / day |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| CAPS | 1-year follow-up |
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Inclusion 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:
The patient meets lifetime DSM-IV-TR criteria for:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Zohar, MD | Chaim Sheba Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Ashkelon | Israel | ||||
| Soroka Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38767196 | Derived | 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. | |
| 35141873 |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Drug |
1-2 capsules |
|
| Beersheba |
| Israel |
| RAMBAM Medical Center | Haifa | Israel |
| Hadassa Medical Center | Jerusalem | Israel |
| Chaim Sheba Medical Center | Ramat Gan | Israel |
| 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. |
| 28703951 | 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. |
| 25885650 | 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. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |