Treatments for Psychogenic Nonepileptic Seizures (NES)

Condition(s) targeted: Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic

Intervention: sertraline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Rhode Island Hospital

Official(s) and/or principal investigator(s):
W. Curt LaFrance, Jr., MD, Principal Investigator, Affiliation: Rhode Island Hospital/Brown Medical School

Overall contact:
W. Curt LaFrance, Jr., MD, Phone: 401-444-3534, Email: William_LaFrance_Jr@Brown.edu

The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone 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.

Official title: Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-Controlled, Double-Blind, 50 Subject Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Number of NES

Secondary outcome:

Identify predictors of response from the following 3 groups: clinical diagnoses

psychological symptoms

socio-demographic variables

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 RO1, 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), 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.

Minimum age: 18 Years. Maximum age: 95 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Video electroencephalogram (EEG) 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 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

W. Curt LaFrance, Jr., MD, Phone: 401-444-3534, Email: William_LaFrance_Jr@Brown.edu

Rhode Island Hospital, Providence, Rhode Island 02903, United States; Recruiting
Peggy McGill, Phone: 401-444-5113, Email: PMcGill@Lifespan.org
Joan Silva, Phone: 401-444-4006, Email: JSilva@Lifespan.org
W. Curt LaFrance, Jr., MD, Principal Investigator
Gabor I. Keitner, MD, Sub-Investigator
Andrew S. Blum, MD, PhD, Sub-Investigator
Ivan Miller, III, PhD, Sub-Investigator
Christine Ryan, PhD, Sub-Investigator

Brown Medical School Clinical Neurosciences

Related publications:

LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. Review.

Curt LaFrance W, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5S):19-23.

LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. No abstract available.

LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; for the NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. Epub 2006 Mar 15.

LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. Epub 2005 Sep 16. Review.

Starting date: December 2003
Ending date: March 2008
Last updated: January 4, 2008