Study Stopped
PI was transferred to another base. No one else available to serve as PI.
Results From a 24 Week Trial of EMDR Combined With Venlafaxine XR
EMDRVEN
Results From a 24 Week, Double-blind, Placebo-controlled Trial of EMDR Combined With Venlafaxine XR in the Treatment of Posttraumatic Stress Disorder
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
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Started Jan 2016
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2015
CompletedFirst Posted
Study publicly available on registry
May 5, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 13, 2016
January 1, 2016
Same day
April 9, 2015
January 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in PTSD symptoms at 12 weeks measured using the CAPS-5 scale
Clinician Administered PTSD Scale for DSM-5
12 weeks
Change in PTSD symptoms at 24 weeks measured using the CAPS-5 scale
Clinician Administered PTSD Scale for DSM-5
24 weeks
Secondary Outcomes (8)
Change in depression symptoms at 12 weeks measured using the PHQ-9 scale
12 weeks
Change in depression symptoms at 24 weeks measured using the PHQ-9 scale
24 weeks
Percentage of participants experiencing adverse events as a measure of safety and tolerability
24 weeks
Attrition percentage as a measure of safety and tolerability
24 weeks
Change in PTSD symptoms at 12 weeks measured using the PCL-5 scale
12 weeks
- +3 more secondary outcomes
Study Arms (2)
EMDR + Venlafaxine XR
EXPERIMENTALParticipants will receive 12 one-hour sessions of EMDR while taking venlafaxine XR 150mg or 225mg for the duration of the 6 month study.
EMDR + Placebo
PLACEBO COMPARATORParticipants will receive 12 one-hour sessions of EMDR while taking placebo 150mg or 225mg for the duration of the 6 month study.
Interventions
Serotonin norepinephrine reuptake inhibitor
psychotherapy
Look-alike venlafaxine XR tablets containing no active drug
Eligibility Criteria
You may qualify if:
- 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 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
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J Lee, MD
Bayne-Jones Army Community Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2015
First Posted
May 5, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 13, 2016
Record last verified: 2016-01