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| Sponsor: | Rhode Island Hospital |
|---|---|
| Collaborators: |
American Epilepsy Society Epilepsy Foundation University of Cincinnati Stanford University |
| Information provided by: | Rhode Island Hospital |
| ClinicalTrials.gov Identifier: | NCT00835627 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures |
| Estimated Enrollment: | 20 |
| 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:
|
|
Active Comparator: Standard care
community care / treatment as usual
|
Other: Standard Care
community care, treatment as usual
Other Name: TAU, standard care
|
This is a pilot, prospective, single 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 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), 20 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. 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: W. Curt LaFrance, Jr., MD, MPH | 401-444-3534 | William_LaFrance_Jr@Brown.edu |
| Contact: Anne Frank Webb | 401-444-9979 | afrankwebb@lifespan.org |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: John Barry, MD 650-498-6743 jbarry@stanford.edu | |
| Contact: Jessica Hawkins 650-723-8323 jhawk@stanford.edy | |
| Principal Investigator: John Barry, MD | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Jerzy P Szaflarski, MD, PhD 513-558-3975 szaflaj@ucmail.uc.edu | |
| Contact: Lucy Mendoza 513-558-3975 mendozlc@ucmail.uc.edu | |
| Principal Investigator: Jerzy P Szaflarski, MD, PhD | |
| United States, Rhode Island | |
| Rhode Island Hospital | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Peggy McGill 401-444-5113 PMcGill@Lifespan.org | |
| Contact: Sandy Deitch 401-444-8556 SDeitch@Lifespan.org | |
| Principal Investigator: W. Curt LaFrance, Jr., MD, MPH | |
| Sub-Investigator: Gabor Keitner, MD | |
| Sub-Investigator: Andrew Blum, MD, PhD | |
| Sub-Investigator: Ivan Miller, III, PhD | |
| Principal Investigator: | W. Curt LaFrance, Jr., MD, MPH | Rhode Island Hospital / Brown Medical School |
More Information
| Responsible Party: | W. Curt LaFrance, Jr., MD, MPH / Director of Neuropsychiatry and Behavioral Neurology, Rhode Island Hospital / Brown Medical School |
| ClinicalTrials.gov Identifier: | NCT00835627 History of Changes |
| Other Study ID Numbers: | EF122982 |
| Study First Received: | January 30, 2009 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Treatment Cognitive Behavior Therapy pharmacotherapy psychogenic nonepileptic seizures |
pseudoseizures dissociative seizures conversion disorder |
|
Conversion Disorder Hysteria Dissociative Disorders Seizures Depression Depressive Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Somatoform Disorders Mental Disorders Histrionic Personality Disorder Personality Disorders Epilepsy Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms Behavioral Symptoms Mood Disorders Anxiety Disorders Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents |
