Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram
Information source: Hadassah Medical Organization
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stress Disorders, Post Traumatic
Intervention: Escitalopram (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hadassah Medical Organization Official(s) and/or principal investigator(s):
Areh Y SHALEV, M.D., Principal Investigator, Affiliation: Hadassah Medical Organization
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.
Clinical Details
Official title: Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Post-traumatic Stress Disorder (PTSD) and PTSD symptoms as recorded by the Clinicians Administered PTSD Scale (CAPS)
Secondary outcome: Proportion of Participants completing the study
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.
Eligibility
Minimum age: 21 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hadassah University Hospital, Jerusalem 91120, Israel
Additional Information
Starting date: September 2008
Last updated: March 21, 2010
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