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Treatment Trial for Psychogenic Nonepileptic Seizures (NEST-T_1)

Primary Purpose

Convulsion, Non-Epileptic, Conversion Disorder, Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline
CBT-ip
Combined (sertraline + CBT-ip)
Standard Care
Sponsored by
Rhode Island Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Convulsion, Non-Epileptic focused on measuring Treatment, Cognitive Behavior Therapy, pharmacotherapy, psychogenic nonepileptic seizures, pseudoseizures, dissociative seizures, conversion disorder

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University
  • University of Cincinnati
  • Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

sertraline

CBT-ip

Combined (sertraline + CBT-ip)

Standard care

Arm Description

flexible dose sertraline

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

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

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

Outcomes

Primary Outcome Measures

seizure frequency

Secondary Outcome Measures

Identify predictors of response from the following 3 groups: clinical diagnoses
psychological symptoms
socio-demographic variables

Full Information

First Posted
January 30, 2009
Last Updated
November 7, 2014
Sponsor
Rhode Island Hospital
Collaborators
American Epilepsy Society, Epilepsy Foundation, University of Cincinnati, Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00835627
Brief Title
Treatment Trial for Psychogenic Nonepileptic Seizures
Acronym
NEST-T_1
Official Title
Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
American Epilepsy Society, Epilepsy Foundation, University of Cincinnati, Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Convulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Dissociative Disorders
Keywords
Treatment, Cognitive Behavior Therapy, pharmacotherapy, psychogenic nonepileptic seizures, pseudoseizures, dissociative seizures, conversion disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sertraline
Arm Type
Active Comparator
Arm Description
flexible dose sertraline
Arm Title
CBT-ip
Arm Type
Active Comparator
Arm Description
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions
Arm Title
Combined (sertraline + CBT-ip)
Arm Type
Active Comparator
Arm Description
flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12 individual, 1 hour therapy sessions
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
community care / treatment as usual: routine follow up with existing providers
Intervention Type
Drug
Intervention Name(s)
sertraline
Other Intervention Name(s)
Zoloft
Intervention Description
flexible dose sertraline
Intervention Type
Behavioral
Intervention Name(s)
CBT-ip
Intervention Description
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions
Intervention Type
Other
Intervention Name(s)
Combined (sertraline + CBT-ip)
Other Intervention Name(s)
Zoloft, CBT-ip
Intervention Description
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
Intervention Name(s)
Standard Care
Other Intervention Name(s)
TAU, standard care
Intervention Description
community care, treatment as usual: routine follow up with existing providers
Primary Outcome Measure Information:
Title
seizure frequency
Time Frame
weekly
Secondary Outcome Measure Information:
Title
Identify predictors of response from the following 3 groups: clinical diagnoses
Time Frame
baseline
Title
psychological symptoms
Time Frame
bi-weekly
Title
socio-demographic variables
Time Frame
bi-weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. Curt LaFrance, Jr., MD, MPH
Organizational Affiliation
Rhode Island Hospital / Brown Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11914432
Citation
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.
Results Reference
background
PubMed Identifier
12609316
Citation
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.
Results Reference
background
PubMed Identifier
15186340
Citation
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.
Results Reference
background
PubMed Identifier
16150653
Citation
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.
Results Reference
background
PubMed Identifier
16540377
Citation
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.
Results Reference
background
PubMed Identifier
16636265
Citation
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.
Results Reference
background
PubMed Identifier
16769930
Citation
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.
Results Reference
background
PubMed Identifier
18070841
Citation
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.
Results Reference
background
PubMed Identifier
18282812
Citation
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.
Results Reference
background
PubMed Identifier
18317280
Citation
LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.
Results Reference
background
PubMed Identifier
24111933
Citation
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.
Results Reference
background
PubMed Identifier
23458467
Citation
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.
Results Reference
background
PubMed Identifier
23281644
Citation
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.
Results Reference
background
PubMed Identifier
21299547
Citation
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.
Results Reference
background
PubMed Identifier
24989152
Citation
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.
Results Reference
result
Links:
URL
http://med.brown.edu/neurology/neuropsychiatry
Description
Brown University Alpert Medical School Neuropsychiatry/Behavioral Neurology

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Treatment Trial for Psychogenic Nonepileptic Seizures

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