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

January 11, 2016 updated by: Bayne-Jones Army Community Hospital

Results From a 24 Week, Double-blind, Placebo-controlled Trial of EMDR Combined With Venlafaxine XR in the Treatment of Posttraumatic Stress Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 150 active duty service members meeting DSM-5 criteria for PTSD and scoring 50 or above on the Clinician Administered PTSD Score for DSM-5 (CAPS-5) will be recruited for a prospective, randomized, double-blinded, controlled trial. Participants will be recruited via referral from other providers or self-referral from recruitment fliers. CAPS-5 is considered the gold-standard for PTSD symptom assessment in research. An initial PHQ-9,PCL-5, urine drug screen, and pregnancy test will be obtained at that visit as well. Qualifying participants will then meet with a prescriber, review informed consent, draw a number for randomization, and complete the SCID-5. The participant will then meet with the pharmacist who will dispense either venlafaxine XR or placebo. Randomization will have occurred before any participants have been recruited. Randomization will consist of use of a random number generator to generate 150 numbers. The pharmacist will secretly assign half of the numbers to treatment and half to control. Numbers generated will be written on slips of paper and placed in opaque envelopes then placed in a box. Participants will then draw their own numbers and inform the researchers of the number drawn. The titration schedule for the venlafaxine XR/placebo will be 3 days at 37.5mg, 7 days at 75mg, then increasing to 150mg. The participant will meet with the prescriber after 4 weeks at 150mg to determine if an increase to 225mg is warranted based on the participants DSM-5 PTSD symptoms. Meetings with a prescriber will then occur monthly throughout the study unless side effects or other concerns require more frequent follow up. Prescriber visits will be scheduled for 30 minutes, however, visits could be completed in as little as five minutes if the medication is working well with no side effects, blood pressure remains at baseline, the participant remains adherent to both medication and therapy, and the participant raises no concerns. Participants will meet with the pharmacist on a monthly basis for pill counts. EMDR sessions will occur weekly if possible and not any less than once every 2 weeks. Two sessions are allowed in 1 week if the participant anticipates going to the field or otherwise being unavailable for regular visits. All EMDR sessions will be recorded using a camcorder and the principal investigator will review 10% of all therapy sessions (a minimum of 1 session per participant) using a fidelity checklist. CAPS-5 assessments will be completed by an individual not involved in a participant's direct treatment and will be administered after completion of EMDR and again at 6 months from the date of his/her first therapy session. A urine drug screen will be ordered with each CAPS-5. Missing data/participant drop out will be handled using last object carried forward. Comparisons between interventions will be computed using a student's T-test for single comparisons between groups or ANOVA when multiple comparisons/time points are involved. If at any point a participant requests a record of treatment, a summary of care will be provided.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EMDR + Venlafaxine XR
Participants will receive 12 one-hour sessions of EMDR while taking venlafaxine XR 150mg or 225mg for the duration of the 6 month study.
Drug: Venlafaxine XR
Serotonin norepinephrine reuptake inhibitor
Other Names:
  • Effexor
Behavioral: EMDR
psychotherapy
Other Names:
  • Eye Movement Desensitization Reprocessing
Placebo Comparator: EMDR + Placebo
Participants will receive 12 one-hour sessions of EMDR while taking placebo 150mg or 225mg for the duration of the 6 month study.
Behavioral: EMDR
psychotherapy
Other Names:
  • Eye Movement Desensitization Reprocessing
Drug: Placebo
Look-alike venlafaxine XR tablets containing no active drug
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in PTSD symptoms at 12 weeks measured using the CAPS-5 scale
Time Frame: 12 weeks
Clinician Administered PTSD Scale for DSM-5
12 weeks
Change in PTSD symptoms at 24 weeks measured using the CAPS-5 scale
Time Frame: 24 weeks
Clinician Administered PTSD Scale for DSM-5
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in depression symptoms at 12 weeks measured using the PHQ-9 scale
Time Frame: 12 weeks
Periodic Health Questionnaire
12 weeks
Change in depression symptoms at 24 weeks measured using the PHQ-9 scale
Time Frame: 24 weeks
Periodic Health Questionnaire
24 weeks
Percentage of participants experiencing adverse events as a measure of safety and tolerability
Time Frame: 24 weeks
24 weeks
Attrition percentage as a measure of safety and tolerability
Time Frame: 24 weeks
24 weeks
Change in PTSD symptoms at 12 weeks measured using the PCL-5 scale
Time Frame: 12 weeks
PTSD Checklist for DSM-5
12 weeks
Change in PTSD symptoms at 24 weeks measured using the PCL-5 scale
Time Frame: 24 weeks
PTSD Checklist for DSM-5
24 weeks
Presence of non-prescribed or illicit drugs on urine drug screen at 12 weeks
Time Frame: 12 weeks
12 weeks
Presence of non-prescribed or illicit drugs on urine drug screen at 24 weeks
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayne-Jones Army Community Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Lee, MD, Bayne-Jones Army Community Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Bayne-Jones

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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