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Treatments for Psychogenic Nonepileptic Seizures (NES)
This study is ongoing, but not recruiting participants.
First Received: September 8, 2005   Last Updated: November 17, 2009   History of Changes
Sponsor: Rhode Island Hospital
Collaborator: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT00159965
  Purpose

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.


Condition Intervention Phase
Convulsion, Non-Epileptic
Conversion Disorder
Depression
Stress Disorders, Post-Traumatic
Drug: sertraline
Drug: placebo
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Rhode Island Hospital:

Primary Outcome Measures:
  • Number of NES [ 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: 50
Study Start Date: December 2003
Estimated Study Completion Date: June 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sertraline: Active Comparator
flexible dose sertraline
Drug: sertraline
flexible dose sertraline
placebo: Placebo Comparator
flexible dose placebo
Drug: placebo
flexible dose placebo

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.

  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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159965

Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Investigators
Principal Investigator: W. Curt LaFrance, Jr., MD Rhode Island Hospital/Brown Medical School
  More Information

Additional Information:
Publications:
Responsible Party: Rhode Island Hospital ( W. Curt LaFrance, Jr., MD, MPH / Director of Neuropsychiatry and Behavioral Neurology )
Study ID Numbers: 5K23 NS 045902-05
Study First Received: September 8, 2005
Last Updated: November 17, 2009
ClinicalTrials.gov Identifier: NCT00159965     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Rhode Island Hospital:
nonepileptic seizure
pseudoseizure
conversion disorder
psychogenic
Depression
Anxiety
Abuse
post-traumatic stress disorder
sertraline
serotonin
randomized controlled trial

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Brain Diseases
Hysteria
Stress Disorders, Traumatic
Signs and Symptoms
Pathologic Processes
Mental Disorders
Therapeutic Uses
Stress Disorders, Post-Traumatic
Sertraline
Antidepressive Agents
Personality Disorders
Disease
Depression
Seizures
Nervous System Diseases
Central Nervous System Diseases
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Anxiety Disorders
Epilepsy
Histrionic Personality Disorder
Mood Disorders

ClinicalTrials.gov processed this record on February 08, 2010