Treatment Trial for Psychogenic Nonepileptic Seizures (NES treatment)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
American Epilepsy Society
Epilepsy Foundation
University of Cincinnati
Stanford University
Information provided by (Responsible Party):
W. Curt LaFrance Jr., M.D., Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00835627
First received: January 30, 2009
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy (CBT) for NES) or combined treatment (CBT + 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.


Condition Intervention Phase
Convulsion, Non-Epileptic
Conversion Disorder
Depression
Stress Disorders, Post-Traumatic
Dissociative Disorders
Drug: sertraline
Behavioral: CBT for NES
Other: Med+CBT
Other: Standard Care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • seizure frequency [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify predictors of response from the following 3 groups: clinical diagnoses [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • psychological symptoms [ Time Frame: bi-weekly ] [ Designated as safety issue: No ]
  • socio-demographic variables [ Time Frame: bi-weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: September 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sertraline
flexible dose sertraline
Drug: sertraline
flexible dose sertraline
Other Name: Zoloft
Active Comparator: CBT
cognitive behavioral therapy for nonepileptic seizures
Behavioral: CBT for NES
cognitive behavioral therapy for nonepileptic seizures
Other Name: CBT
Active Comparator: med+CBT
flexible dose sertraline and cognitive behavioral therapy for nonepileptic seizures
Other: Med+CBT
flexible dose sertraline and cognitive behavioral therapy for nonepileptic seizures
Other Names:
  • Zoloft
  • CBT
Active Comparator: Standard care
community care / treatment as usual
Other: Standard Care
community care, treatment as usual
Other Name: TAU, standard care

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 (CBT), combined therapy (sertraline + CBT) 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 arm will receive 12 weekly sessions of CBT for NES. Those randomized to the CBT+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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835627

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
American Epilepsy Society
Epilepsy Foundation
University of Cincinnati
Stanford University
Investigators
Principal Investigator: W. Curt LaFrance, Jr., MD, MPH Rhode Island Hospital / Brown Medical School
  More Information

Additional Information:
Publications:

Responsible Party: W. Curt LaFrance Jr., M.D., Director, Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00835627     History of Changes
Other Study ID Numbers: EF122982
Study First Received: January 30, 2009
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
Treatment
Cognitive Behavior Therapy
pharmacotherapy
psychogenic nonepileptic seizures
pseudoseizures
dissociative seizures
conversion disorder

Additional relevant MeSH terms:
Conversion Disorder
Dissociative Disorders
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Somatoform Disorders
Mental Disorders
Histrionic Personality Disorder
Personality Disorders
Mood Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anxiety Disorders
Hysteria
Depression
Seizures
Behavioral Symptoms
Epilepsy
Neurologic Manifestations
Signs and Symptoms
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents

ClinicalTrials.gov processed this record on April 23, 2014