Stress Disorders, Post Traumatic Clinical Trial
Official title:
Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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