NCT00835627

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

4.3 years

First QC Date

January 30, 2009

Last Update Submit

November 7, 2014

Conditions

Convulsion, Non-EpilepticConversion DisorderDepressionStress Disorders, Post-TraumaticDissociative Disorders

Keywords

TreatmentCognitive Behavior Therapypharmacotherapypsychogenic nonepileptic seizurespseudoseizuresdissociative seizuresconversion disorder

Outcome Measures

Primary Outcomes (1)

  • seizure frequency

    weekly

Secondary Outcomes (3)

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

    baseline

  • psychological symptoms

    bi-weekly

  • socio-demographic variables

    bi-weekly

Study Arms (4)

sertraline

ACTIVE COMPARATOR

flexible dose sertraline

Drug: sertraline

CBT-ip

ACTIVE COMPARATOR

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

Behavioral: CBT-ip

Combined (sertraline + CBT-ip)

ACTIVE COMPARATOR

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

Other: Combined (sertraline + CBT-ip)

Standard care

ACTIVE COMPARATOR

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

Other: Standard Care

Interventions

sertralineDRUG

flexible dose sertraline

Also known as: Zoloft
sertraline
CBT-ipBEHAVIORAL

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

CBT-ip
Combined (sertraline + CBT-ip)OTHER

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

Also known as: Zoloft, CBT-ip
Combined (sertraline + CBT-ip)
Standard CareOTHER

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

Also known as: TAU, standard care
Standard care

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University

Stanford, California, 94305, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (15)

  • 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.

    PMID: 11914432BACKGROUND

  • 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.

    PMID: 12609316BACKGROUND

  • 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.

    PMID: 15186340BACKGROUND

  • 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.

    PMID: 16150653BACKGROUND

  • 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.

    PMID: 16540377BACKGROUND

  • 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.

    PMID: 16636265BACKGROUND

  • 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.

    PMID: 16769930BACKGROUND

  • 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.

    PMID: 18070841BACKGROUND

  • 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.

    PMID: 18282812BACKGROUND

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

    PMID: 18317280BACKGROUND

  • 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.

    PMID: 24111933BACKGROUND

  • 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.

    PMID: 23458467BACKGROUND

  • 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.

    PMID: 23281644BACKGROUND

  • 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.

    PMID: 21299547BACKGROUND

  • 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.

    PMID: 24989152RESULT

MeSH Terms

Conditions

SeizuresConversion DisorderDepressionStress Disorders, Post-TraumaticDissociative DisordersPsychogenic Nonepileptic Seizures

Interventions

SertralineStandard of Care

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSomatoform DisordersMental DisordersBehavioral SymptomsBehaviorStress Disorders, TraumaticTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • W. Curt LaFrance, Jr., MD, MPH

    Rhode Island Hospital / Brown Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Neuropsychiatry and Behavioral Neurology

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 3, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(3)