Treatment Trial for Psychogenic Nonepileptic Seizures

Depression Clinical Trial

— NEST-T_1  

Official title:

Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00835627
• Other study ID #: EF122982
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2009
• Last updated: November 7, 2014
• Start date: September 2008
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• sertraline
flexible dose sertraline

Behavioral:
• CBT-ip
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions

Other:
• 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
• Standard Care
community care, treatment as usual: routine follow up with existing providers

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Stanford University	Stanford	California

Sponsors (5)

Lead Sponsor	Collaborator
Rhode Island Hospital	American Epilepsy Society, Epilepsy Foundation, Stanford University, University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View 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. Epub 2006 Mar 15. — View 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 — View 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. Review. — View Citation

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. — View Citation

LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. — View 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. — View 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. — View Citation

LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. Review. — View Citation

LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. — View 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. Review. — View 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. — View Citation

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

LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure frequency		weekly	No
Secondary	Identify predictors of response from the following 3 groups: clinical diagnoses		baseline	No
Secondary	psychological symptoms		bi-weekly	No
Secondary	socio-demographic variables		bi-weekly	No

External Links

•   Brown University Alpert Medical School Neuropsychiatry/Behavioral Neurology
•   NINDS/NIMH/AES NES Treatment Workshop