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

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayne-Jones Army Community Hospital
• Treatments: Venlafaxine Hydrochloride

Criteria

Inclusion:

• Initial CAPS-5 score of 50 or greater

• Meeting criteria for PTSD using DSM-5 criteria

• Open to active duty US service members of all genders, races / ethnicities, religions, sexual orientations, and marital statuses

• Participants can have a history of mild TBI, past or current substance abuse, nicotine dependence, chronic pain, migraines/headaches, and most other medical illnesses not specified in exclusion section

• Participants can be taking opiates, a sleep aid, and/or prazosin for an indication of PTSD nightmares provided dosing does not exceed 15mg (men) / 9mg (women). Dosing more than once per day is not permitted

Exclusion:

• Current suicidal or homicidal ideation

• Pregnancy

• Profound hearing loss

• HIV and AIDS

• Current chemotherapy

• Primary thought disorders

• Bipolar disorder or cyclothymia

• Current substance dependence (not including nicotine)

• Current use of bupropion above 150mg daily

• Current use of mirtazapine above 15mg daily

• Current use of an SSRI

• Current use of another SNRI

• Current use of tricyclic antidepressants in doses above 50mg

• Current use of an MAO-I

• Current use of a stimulant

• Current use of a mood stabilizer/anti-epileptic for an indication of mood stability or reduction in anger

• Current use of an anti-psychotic

• Current use of lithium

• Chronic daily use of steroids

• Current use of tapentadol

• Current use of dronabinol

• Current use of ketamine