SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and PTSD in Physical Trauma Victims

NCT00114374 | Terminated Phase 3

• 1 other identifier: 2004-P-001633
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the efficacy of escitalopram compared to placebo in reducing Acute Stress Disorder (ASD) symptoms and in preventing the emergence of Post-Traumatic Stress Disorder (PTSD) in patients with medical trauma who are at risk for the development of PTSD based on the presence of ASD symptoms.

Conditions

Anxiety Disorder

Keywords

Acute Stress Disorder; Posttraumatic Stress Disorder; Escitalopram; Double-Blind

Outcome Measures

Primary Outcomes (2)

• Symptoms of Acute Stress Disorder

• Symptoms of Posttraumatic Stress Disorder

Secondary Outcomes (1)

• Clinical Global Improvement

Interventions

Escitalopram DRUG

Eligibility Criteria

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

You may qualify if:

• Male or female outpatients at least 18 years of age with a primary (the condition that is most central to the patient's current distress) symptoms of Acute Stress Disorder as defined by DSM-IV criteria: A1, A2 and at least one additional category of Acute Stress Disorder symptoms (i.e., B, C and or D criteria).
• Patients must have had a medical trauma (even if fully resolved or minor) within the prior 3 weeks resulting in admission to the emergency room and/or inpatient hospital as part of their acute trauma resulting in ASD symptoms.

You may not qualify if:

• Pregnant or lactating women or those of childbearing potential not using medically accepted forms of contraception will be excluded.
• Concurrent use of other antidepressants, with the exception of trazodone \< 100mg/day for sleep, or amitriptyline in doses ≤ 50 mg daily for pain. Patients may remain on concomitant benzodiazepines (\<2 mg/d clonazepam or its equivalent), or sleep aids (i.e., trazodone, zolpidem (Ambien), zaleplon (Sonata)) as long as the drug therapy was initiated at 1 week prior to randomization; the dose will be held constant through the study, and will be controlled for in the analysis.
• Patients with a history of hypersensitivity or prior poor response to escitalopram are excluded.
• Concurrent dynamic or supportive psychotherapy is permitted as long as it has been ongoing for at least 1 month prior to onset of study entry.
• Patients with a positive toxicology screen at baseline consistent with evidence of current substance abuse or dependence as determined by clinical interview.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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

Related Links

• Official Website for the Center for Anxiety and Traumatic Stress Disorders

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Traumatic, Acute; Stress Disorders, Post-Traumatic

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Naomi M Simon, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2005
• First Posted: June 15, 2005
• Study Start: June 1, 2005
• Study Completion: June 1, 2007
• Last Updated: June 9, 2014

Record last verified: 2014-06

Locations

US (1)