Depression Clinical Trial
Official title:
Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures
The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.
This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the
number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive
behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip)
or community care (treatment as usual TAU). This study will provide outcomes data and the
effect size necessary for a future R01, multi-center randomized control trial. Secondary
objective variables include reduction in depression, anxiety, impulsivity scores, and
improvement in psychosocial functioning.
After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be
enrolled and monitored during a two week lead in period for their baseline NES and
psychosocial symptoms and functioning. At week 2, they will be randomized to either:
flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU.
Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or
to dose limited by side effects. The subjects will stay on their maximum fixed dose for the
next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can
taper off the medication over the final two weeks of the treatment trial. Those randomized
to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the
CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow
with their treatment providers.
After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and
12 after enrollment to assess seizure status, medication usage, and global functioning.
Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological
exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and
function scales. They will keep a seizure diary to evaluate their daily seizure activity.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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