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Treatment Trial for Psychogenic Nonepileptic Seizures

NCT ID: NCT00835627

Last Updated: 2014-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Convulsion, Non-Epileptic Conversion Disorder Depression Stress Disorders, Post-Traumatic Dissociative Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sertraline

flexible dose sertraline

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

flexible dose sertraline

CBT-ip

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions

Group Type ACTIVE_COMPARATOR

CBT-ip

Intervention Type BEHAVIORAL

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions

Combined (sertraline + CBT-ip)

flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions

Group Type ACTIVE_COMPARATOR

Combined (sertraline + CBT-ip)

Intervention Type OTHER

flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions

Standard care

community care / treatment as usual: routine follow up with existing providers

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type OTHER

community care, treatment as usual: routine follow up with existing providers

Interventions

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sertraline

flexible dose sertraline

Intervention Type DRUG

CBT-ip

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions

Intervention Type BEHAVIORAL

Combined (sertraline + CBT-ip)

flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions

Intervention Type OTHER

Standard Care

community care, treatment as usual: routine follow up with existing providers

Intervention Type OTHER

Other Intervention Names

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Zoloft Zoloft CBT-ip TAU, standard care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Epilepsy Society

OTHER

Sponsor Role collaborator

Epilepsy Foundation

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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W. Curt LaFrance Jr., M.D.

Director, Neuropsychiatry and Behavioral Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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W. Curt LaFrance, Jr., MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital / Brown Medical School

Locations

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Stanford University

Stanford, California, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. doi: 10.1212/wnl.58.6.990. No abstract available.

Reference Type BACKGROUND
PMID: 11914432 (View on PubMed)

LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. doi: 10.1016/s1525-5069(02)00505-4.

Reference Type BACKGROUND
PMID: 12609316 (View on PubMed)

LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.

Reference Type BACKGROUND
PMID: 15186340 (View on PubMed)

LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.

Reference Type BACKGROUND
PMID: 16150653 (View on PubMed)

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. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.

Reference Type BACKGROUND
PMID: 16540377 (View on PubMed)

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. doi: 10.1212/01.wnl.0000222496.94195.14. No abstract available.

Reference Type BACKGROUND
PMID: 16636265 (View on PubMed)

LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. doi: 10.1212/01.wnl.0000224953.94807.be. No abstract available.

Reference Type BACKGROUND
PMID: 16769930 (View on PubMed)

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. doi: 10.1176/jnp.2007.19.4.391.

Reference Type BACKGROUND
PMID: 18070841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18282812 (View on PubMed)

LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.

Reference Type BACKGROUND
PMID: 18317280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24111933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23458467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23281644 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21299547 (View on PubMed)

LaFrance WC Jr, Baird GL, Barry JJ, Blum AS, Frank Webb A, Keitner GI, Machan JT, Miller I, Szaflarski JP; NES Treatment Trial (NEST-T) Consortium. Multicenter pilot treatment trial for psychogenic nonepileptic seizures: a randomized clinical trial. JAMA Psychiatry. 2014 Sep;71(9):997-1005. doi: 10.1001/jamapsychiatry.2014.817.

Reference Type RESULT
PMID: 24989152 (View on PubMed)

Other Identifiers

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EF122982

Identifier Type: -

Identifier Source: org_study_id