NYU – Pfizer Drug Trial: Scared Shitless, Beyond Ready
Tomorrow – off to New York for my first round of PTSD-specific research medication. As nervous as I am, I feel so incredibly lucky to be able to participate.
It’s been a very long road getting to this point. Thousands of miles travelled, extensive psychological and physical workups, brain scans…but it has been as validating as it has been exhausting. TEN MONTHS of planning and preparation. I have been taken off and put back on my medications FIVE TIMES due to false starts. I am fried.
But here I am, FINALLY. After all this time, all the delays, all the highs, all the lows – it’s time.
But I am ready. I have let go of all expectations. What happens, happens. I am focused on just getting through the next three weeks. I accept the fact that this is going to be an incredible challenge.
I know and understand that I’m going to be deliberately triggered repeatedly. More pokes, more prods, more questions, more scans. I know I will very likely melt down. I know that this medication may not even work.
I also know that I’ll be surrounded by some of the most qualified and brilliant minds in PTSD research – and I trust their knowledge and ethics. I know that they will take excellent care of me.
Most importantly, I trust myself and my ability to make it through this process and keep on moving forward, regardless of the outcome.
I recently read on a wonderful blog that those of us with Complex PTSD constantly live outside our comfort zone. That statement is so true. I may live outside of my comfort zone – but I am LIVING.
Life doesn’t have to be easy to be good. You just have to keep putting one foot in front of the other, and welcome each bump, bruise and bloody knee with an open heart.
And so…here we go. Wish me luck. Here’s what I’m diving into:
Title of Study: A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2 STUDY TO ASSESS EFFECTS OF PF-04457845 ON BOLD FUNTIONAL MRI IN SUBJECTS WITH PTSD
On ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02216097
The purpose of this study is to evaluate the effects of an investigational drug, PF-04457845, on functional magnetic resonance imaging (fMRI) and behavioral tasks in people with Post Traumatic Stress Disorder (PTSD). PF-04457845 is investigational because it is not approved by the Food and Drug Administration (FDA) for PTSD. fMRI is an imaging technique that uses magnets and detection of changes in blood flow to create images of brain activity.
Your participation will involve 5 visits….each of these visits will take the following amount of time:
Visit 1 (screening) will take approximately 4-5 hours at New York University (NYU) School of Medicine, New York, NY.
Visit 2 (fMRI scan, first day of investigational drug dosing) will take approximately one full day at NYU School of Medicine, Clinical and Translational Science Institute (CTSI), and NYU Center for Biomedical Imaging (CBI), New York, NY.
Visit 3 (fMRI scan, second day of investigational drug dosing) and visit 4 (fMRI scan, 1-2 days after the last dose of investigational drug) will take approximately 2-3 hours at the NYU CBI.
Visit 5 is the follow-up visit, scheduled approximately 10-17 days after the first dose of the investigational drug, and takes place at NYU School of Medicine.
You will be asked to undergo a screening session, a baseline visit, which includes 2 sessions of fMRI scanning before and after the first dose of the experimental drug, a third fMRI scanning session the day after the first dose of the experimental drug, a fourth fMRI scanning session about a week after taking the first dose of the experimental drug, and one follow-up visit. During the period of the study, you will be provided with emergency contact information in the event that you experience any negative side effects from taking the experimental drug.