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Results From a 24 Week Trial of EMDR Combined With Venlafaxine XR

NCT02433353 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-01-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Venlafaxine XR

Serotonin norepinephrine reuptake inhibitor

BEHAVIORAL

EMDR

psychotherapy

DRUG

Placebo

Look-alike venlafaxine XR tablets containing no active drug

Sponsors & Collaborators

  • Bayne-Jones Army Community Hospital

    lead FED

Principal Investigators

  • Daniel J Lee, MD · Bayne-Jones Army Community Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02433353 on ClinicalTrials.gov