Treatments for Psychogenic Nonepileptic Seizures (NES)

Lifespan

Status and phase: Completed; Phase 4

Conditions: Convulsion, Non-Epileptic; Stress Disorders, Post-Traumatic; Depression; Conversion Disorder

Treatments: Drug: sertraline; Drug: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00159965

5K23NS045902-05

5K23NS045902 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Video electroencephalogram (vEEG) confirmed diagnosis of NES
• Have at least one nonepileptic seizure per month
• Comorbid diagnosis of either depression, anxiety, or post traumatic stress disorder (PTSD)
• Able to complete self report symptom scales
• Not receiving optimized antidepressant medication

Exclusion criteria

• Equivocal electroencephalogram (EEG) findings
• Current suicidality, litigation, or self-mutilation
• Using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
• Allergy/sensitivity to sertraline
• Current alcohol/drug dependence
• Serious medical illness requiring current hospitalization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups, including a placebo group

sertraline

Active Comparator group

Description:

flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES

Treatment:

Drug: sertraline

placebo

Placebo Comparator group

Description:

flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES

Treatment:

Drug: placebo