Results From a 24 Week Trial of EMDR Combined With Venlafaxine XR
Status:
Withdrawn
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
Approximately 150 active duty service members meeting Diagnostic and Statistical Manual
version 5 (DSM-5) criteria for posttraumatic stress disorder (PTSD) and scoring 50 or above
on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited. Qualifying
participants will be randomized on a 1:1 basis to either the eye movement desensitization
reprocessing (EMDR) plus venlafaxine XR group or the EMDR plus placebo group. Protocol will
call for participants to complete 12 one-hour EMDR session while taking a venlafaxine
XR/placebo dose of 150mg or 225mg for the entire 24 weeks. Both prescribers and therapists
will be blinded and CAPS-5 assessments will be completed by an individual not involved in a
participant's direct treatment. An unblinded pharmacist will dispense medication or placebo
according the instructions of the prescriber and will count remaining tablets to measure
compliance. All EMDR sessions will be recorded and will be reviewed by the principal
investigator using a fidelity checklist. CAPS-5 will be administered after completion of EMDR
and again at 6 months from the date of his/her first therapy session.