Treatment Trial for Psychogenic Nonepileptic Seizures (NEST-T_1)

November 7, 2014 updated by: W. Curt LaFrance Jr., M.D., Rhode Island Hospital

Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: sertraline
flexible dose sertraline
Drug: sertraline
flexible dose sertraline
Other Names:
  • Zoloft
Active Comparator: CBT-ip
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual, 1 hour therapy sessions
Behavioral: CBT-ip
cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions
Active Comparator: 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
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
Other Names:
  • Zoloft
  • CBT-ip
Active Comparator: Standard care
community care / treatment as usual: routine follow up with existing providers
Other: Standard Care
community care, treatment as usual: routine follow up with existing providers
Other Names:
  • TAU, standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
seizure frequency
Time Frame: weekly
weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify predictors of response from the following 3 groups: clinical diagnoses
Time Frame: baseline
baseline
psychological symptoms
Time Frame: bi-weekly
bi-weekly
socio-demographic variables
Time Frame: bi-weekly
bi-weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

Stanford University
University of Cincinnati
American Epilepsy Society
Epilepsy Foundation

Investigators

  • Principal Investigator: W. Curt LaFrance, Jr., MD, MPH, Rhode Island Hospital / Brown Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

January 30, 2009

First Submitted That Met QC Criteria

January 30, 2009

First Posted (Estimate)

February 3, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF122982

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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