Treatment Trial for Psychogenic Nonepileptic Seizures

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

Intervention: sertraline (Drug); CBT for NES (Behavioral); Med+CBT (Other); Standard Care (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Rhode Island Hospital

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

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy (CBT) for NES) or combined treatment (CBT + 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.

Official title: Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: seizure frequency

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 controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy (CBT), combined therapy (sertraline + CBT) or community care (treatment as usual TAU). 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), 20 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 arm will receive 12 weekly sessions of CBT. Those randomized to the CBT+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.

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

- Able to complete self report symptom scales

- Not receiving optimized sertraline

Exclusion Criteria:

- Equivocal EEG findings

- 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, MPH, 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
Sandy Deitch, Phone: 401-444-8556, Email: SDeitch@Lifespan.org
W. Curt LaFrance, Jr., MD, MPH, Principal Investigator
Gabor Keitner, MD, Sub-Investigator
Andrew Blum, MD, PhD, Sub-Investigator
Ivan Miller, III, PhD, Sub-Investigator
Christine Ryan, PhD, Sub-Investigator

Brown Medical School Clinical Neurosciences

NINDS/NIMH/AES NES Treatment Workshop

Related publications:

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.

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

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

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.

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. Use of serum prolactin in diagnosing epileptic seizures: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2006 Apr 25;66(8):1287-8; author reply 1287-8. No abstract available.

LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. No abstract available.

LaFrance WC Jr. Treating patients with functional symptoms: one size does not fit all. J Psychosom Res. 2007 Dec;63(6):633-5. No abstract available.

LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8.

LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. Epub 2008 Feb 20.

LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. Review.

Starting date: September 2008
Ending date: June 2011
Last updated: September 11, 2009