NCT00159965

Brief 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.

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 Dec 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 25, 2011

Completed
Last Updated

November 20, 2014

Status Verified

November 1, 2014

Enrollment Period

4.5 years

First QC Date

September 8, 2005

Results QC Date

August 11, 2010

Last Update Submit

November 7, 2014

Conditions

Convulsion, Non-EpilepticConversion DisorderDepressionStress Disorders, Post-Traumatic

Keywords

nonepileptic seizurepseudoseizureconversion disorderpsychogenicDepressionAnxietyAbusepost-traumatic stress disordersertralineserotoninrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Number of Nonepileptic Seizures (NES)

    psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.

    bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12

Secondary Outcomes (13)

  • Beck Depression Inventory-II (BDI-II)

    bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12

  • Modified Hamilton Depression Scale (MHRS)

    Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

  • Global Assessment of Functioning (GAF)

    Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

  • Davidson Trauma Scale (DTS)

    Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

  • Barratt Impulsivity Scale (BIS)

    Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)

  • +8 more secondary outcomes

Study Arms (2)

sertraline

ACTIVE COMPARATOR

flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES

Drug: sertraline

placebo

PLACEBO COMPARATOR

flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES

Drug: placebo

Interventions

sertralineDRUG

flexible dose sertraline

Also known as: Zoloft
sertraline
placeboDRUG

flexible dose placebo

placebo

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (11)

  • 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. 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, 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, 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, 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, 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, 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: 18070841RESULT

  • LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.

    PMID: 19652140RESULT

  • LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.

    PMID: 20739647RESULT

MeSH Terms

Conditions

SeizuresConversion DisorderDepressionStress Disorders, Post-TraumaticPsychogenic Nonepileptic SeizuresAnxiety Disorders

Interventions

Sertraline

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 Compounds

Limitations and Caveats

pilot sample size; drop-outs because of some patient's concern that they would receive the placebo, despite the equipoise that exists for NES treatment(s). Excluding patients who did not have vEEG may present a potential sampling bias.

Results Point of Contact

Title
W. Curt LaFrance, Jr., MD, MPH
Organization
Rhode Island Hospital
William_LaFrance_Jr@Brown.edu
401-444-3534

Study Officials

  • W. Curt LaFrance, Jr., MD, MPH

    Rhode Island Hospital/Brown Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2003

Primary Completion

June 1, 2008

Study Completion

June 1, 2009

Last Updated

November 20, 2014

Results First Posted

January 25, 2011

Record last verified: 2014-11

Locations

US(1)