Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram

NCT00736021 | Completed

• 1 other identifier: HMO_SHALEV_02
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic events. Forty survivors of carefully documented traumatic events who had been followed for more than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve weeks Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical impression, as well as emergent side effects will be recorded every two weeks (one week for the first four weeks. The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or the last meeting with the patient - Last Observation Carried Forward). The secondary outcome criteria will be treatment continuation, as expressed in the proportion of patients leaving the study for either lack of effect or side effects.

Conditions

Stress Disorders, Post Traumatic

Keywords

PTSD; Pharmacological Treatment; SSRI; Escitalopram; Anxiety Disorders

Outcome Measures

Primary Outcomes (1)

• Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)

  Twelve Weeks on Active Medication

Secondary Outcomes (1)

• Proportion of Participants completing the study

  twelve weeks of active treatment

Study Arms (1)

A

EXPERIMENTAL

Single arm (open label study): Provide twelve weeks of treatment with high does (40 mg daily) of escitalopram to trauma survivors with chronic PTSD.

Drug: Escitalopram

Interventions

Escitalopram DRUG

Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily

Also known as: Lexapro, Cipralex

A

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult survivors of traumatic events with chronic PTSD

You may not qualify if:

• Individuals with past history of psychotic disorder, bipolar disorder, opiate or stimulants abuse.
• Individuals currently on anti-depressant therapy.
• Individuals with past history of a failure to respond to escitalopram
• Pregnant Women
• Medical condition excluding the treatment with escitalopram (e.g., renal or hepatic insufficiency). Current, life threatening medical illness. History or severe side effects with escitalopram (e.g., hyponatremia)

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

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

Interventions

Escitalopram; Dexetimide

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; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Areh Y SHALEV, M.D.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 15, 2008
• Study Start: September 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 23, 2010

Record last verified: 2008-09

Locations

IL (1)