Treatments for Psychogenic Nonepileptic Seizures (NES)
Condition: Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic
MeSH terms: Seizures; Psychogenic Nonepileptic Seizures; Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Conversion Disorder; Hysteria; Dissociative Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose that treatment of the comorbid disorders (depression, anxiety, and
      impulsivity) with sertraline in patients with lone psychogenic nonepileptic seizures (NES),
      will result in a decreased number of NES. The purpose of this study is to provide pilot
      testing and data to inform the future randomized controlled trial based on the hypothesis.
    

Detailed description: 
      This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind
      trial, that assesses the number of NES in patients treated with flexible dose sertraline
      (Zoloft). 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 electroencephalogram monitoring (vEEG), up to 50
      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 blindly
      randomized to the treatment arm with flexible dose sertraline (25 to 200mg) or to the placebo
      control arm. The dose will be titrated over 4 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.

      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 prospectively, to evaluate their daily
      seizure activity. They will be given two weeks of the medication at each visit.

      In the first phase of the study 12 patients were screened and 8 enrolled in an open label
      trial of flexible dose sertraline. In the second phase of the study, 38 patients enrolled in
      the pilot, randomized, placebo-controlled trial.
    

Intervention name(s): sertraline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): flexible dose sertraline; flexible dose placebo
Other intervention name(s): Zoloft
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nonepileptic seizure; pseudoseizure; conversion disorder; psychogenic; Depression; Anxiety; Abuse; post-traumatic stress disorder; sertraline; serotonin; randomized controlled trial