Treatment Trial for Psychogenic Nonepileptic Seizures
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; Dissociative Disorders
Intervention: sertraline (Drug); CBT-ip (Behavioral); Combined (sertraline + CBT-ip) (Other); Standard Care (Other)
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 patients who receive targeted pharmacotherapy (sertraline) or
focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES)
or combined treatment (CBT-ip + 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.
Clinical Details
Official title: Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: seizure frequency
Secondary outcome: Identify predictors of response from the following 3 groups: clinical diagnosespsychological symptoms socio-demographic variables
Detailed description:
This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the
number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive
behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip)
or community care (treatment as usual TAU). 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 EEG monitoring (vEEG), up to 40 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-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the
CBT-ip + 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.
Eligibility
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
Locations and Contacts
Stanford University, Stanford, California 94305, United States
University of Cincinnati, Cincinnati, Ohio 45267, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Brown University Alpert Medical School Neuropsychiatry/Behavioral Neurology 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. LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):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; 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. LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. 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. 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, Baker GA, Duncan R, Goldstein LH, Reuber M. Minimum requirements for the diagnosis of psychogenic nonepileptic seizures: a staged approach: a report from the International League Against Epilepsy Nonepileptic Seizures Task Force. Epilepsia. 2013 Nov;54(11):2005-18. doi: 10.1111/epi.12356. Epub 2013 Sep 20. Review. LaFrance WC Jr, Reuber M, Goldstein LH. Management of psychogenic nonepileptic seizures. Epilepsia. 2013 Mar;54 Suppl 1:53-67. doi: 10.1111/epi.12106. Review. LaFrance WC Jr, Deluca M, Machan JT, Fava JL. Traumatic brain injury and psychogenic nonepileptic seizures yield worse outcomes. Epilepsia. 2013 Apr;54(4):718-25. doi: 10.1111/epi.12053. Epub 2013 Jan 2. LaFrance WC Jr, Alosco ML, Davis JD, Tremont G, Ryan CE, Keitner GI, Miller IW, Blum AS. Impact of family functioning on quality of life in patients with psychogenic nonepileptic seizures versus epilepsy. Epilepsia. 2011 Feb;52(2):292-300. doi: 10.1111/j.1528-1167.2010.02765.x. Epub 2011 Feb 7.
Starting date: September 2008
Last updated: November 7, 2014
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