Treatments for Psychogenic Nonepileptic Seizures (NES) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

November 17, 2009

Start Date ^ICMJE

December 2003

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of NES [ Time Frame: weekly ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Number of NES

Change History

Complete list of historical versions of study NCT00159965 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

Treatments for Psychogenic Nonepileptic Seizures (NES)

Official Title ^ICMJE

Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, 50 Subject Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES

Brief Summary

The investigators propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone 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.

Detailed Description

This is a pilot, prospective, single center, randomized, placebo-controlled, double-blind trial, that assesses the number of NES in patients treated with flexible dose sertraline (Zoloft). This study will provide outcomes data and the effect size necessary for a future RO1, 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), 50 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 blindly randomized to the treatment arm with flexible dose sertraline (25 to 200mg) or to the placebo control arm. The dose will be titrated over 4 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.

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 prospectively, to evaluate their daily seizure activity. They will be given two weeks of the medication at each visit.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Single Group Assignment
Masking:  Double Blind (Subject, Investigator)
Primary Purpose:  Treatment

Condition ^ICMJE

Convulsion, Non-Epileptic
Conversion Disorder
Depression
Stress Disorders, Post-Traumatic

Intervention ^ICMJE

Drug: sertraline
flexible dose sertraline

Other Name: Zoloft
Drug: placebo
flexible dose placebo

Study Arms / Comparison Groups

sertraline: Active Comparator
flexible dose sertraline

Intervention: Drug: sertraline
placebo: Placebo Comparator
flexible dose placebo

Intervention: Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Video electroencephalogram (EEG) 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

Exclusion Criteria:

Equivocal 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

Gender

Both

Ages

18 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00159965

Responsible Party

W. Curt LaFrance, Jr., MD, MPH / Director of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital

Study ID Numbers ^ICMJE

5K23 NS 045902-05

Study Sponsor ^ICMJE

Rhode Island Hospital

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

W. Curt LaFrance, Jr., MD

Rhode Island Hospital/Brown Medical School

Information Provided By

Rhode Island Hospital

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP