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

Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00736021

Enrollment

Registered

2008-08-15

Start date

2008-09-30

Completion date

2010-03-31

Last updated

2010-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders, Post Traumatic

Keywords

PTSD, Pharmacological Treatment, SSRI, Escitalopram, Anxiety Disorders

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.

Detailed description

The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of chronic post-traumatic stress disorder (PTSD) Forty adult 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.

Interventions

DRUGEscitalopram

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Adult survivors of traumatic events with chronic PTSD

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)	Twelve Weeks on Active Medication

Secondary

Measure	Time frame
Proportion of Participants completing the study	twelve weeks of active treatment

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026