Treatments for Psychogenic Nonepileptic Seizures (NES)
Information source: Rhode Island Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Convulsion, Non-Epileptic; Conversion Disorder; Depression; Stress Disorders, Post-Traumatic
Intervention: sertraline (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Rhode Island Hospital Official(s) and/or principal investigator(s): W. Curt LaFrance, Jr., MD, MPH, Principal Investigator, Affiliation: Rhode Island Hospital/Brown Medical School
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.
Clinical Details
Official title: Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Number of Nonepileptic Seizures (NES)
Secondary outcome: Beck Depression Inventory-II (BDI-II)Modified Hamilton Depression Scale (MHRS) Global Assessment of Functioning (GAF) Davidson Trauma Scale (DTS) Barratt Impulsivity Scale (BIS) Dissociative Experiences Scale (DES) Symptom Checklist 90 (SCL-90) Oxford Handicap Scale (OHS) Clinical Global Impressions - Severity (CGI-S) Clinical Global Impressions - Improvement (CGI-I) Family Assessment Device (FAD) Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) Quality of Life in Epilepsy-31 (QOLIE-31)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 95 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Brown Medical School Clinical Neurosciences NINDS/NIMH/AES NES Treatment Workshop
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. LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. 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; 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. LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. doi: 10.1016/j.yebeh.2007.12.017. Epub 2008 Feb 20. LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f. Review. LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1.
Starting date: December 2003
Last updated: November 7, 2014
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