Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02433353
Status:
WITHDRAWN
Last Update Posted:
2016-01-13
First Post:
2015-04-09
Brief Title:
Results From a 24 Week Trial of EMDR Combined With Venlafaxine XR
Sponsor:
Bayne-Jones Army Community Hospital
Organization:
Bayne-Jones Army Community Hospital
Study Overview
Official Title:
Results From a 24 Week Double-blind Placebo-controlled Trial of EMDR Combined With Venlafaxine XR in the Treatment of Posttraumatic Stress Disorder
Status:
WITHDRAWN
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI was transferred to another base No one else available to serve as PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMDRVEN
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 11 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 XRplacebo 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 participants 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 hisher first therapy session
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-9PCL-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 XRplacebo will be 3 days at 375mg 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 participants direct treatment and will be administered after completion of EMDR and again at 6 months from the date of hisher first therapy session A urine drug screen will be ordered with each CAPS-5 Missing dataparticipant drop out will be handled using last object carried forward Comparisons between interventions will be computed using a students T-test for single comparisons between groups or ANOVA when multiple comparisonstime points are involved If at any point a participant requests a record of treatment a summary of care will be provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None