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| 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 psychogenic 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: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES |
| Enrollment: | 38 |
| Study Start Date: | December 2003 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: sertraline
flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
|
Drug: sertraline
flexible dose sertraline
Other Name: Zoloft
|
|
Placebo Comparator: placebo
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
|
Drug: placebo
flexible dose placebo
|
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 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 electroencephalogram monitoring (vEEG), up to 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.
In the first phase of the study 12 patients were screened and 8 enrolled in an open label trial of flexible dose sertraline. In the second phase of the study, 38 patients enrolled in the pilot, randomized, placebo-controlled trial.
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| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| 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 |
| ClinicalTrials.gov Identifier: | NCT00159965 History of Changes |
| Other Study ID Numbers: | 5K23 NS 045902-05, 5K23NS045902 |
| Study First Received: | September 8, 2005 |
| Results First Received: | August 11, 2010 |
| Last Updated: | January 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
nonepileptic seizure pseudoseizure conversion disorder psychogenic Depression Anxiety |
Abuse post-traumatic stress disorder sertraline serotonin randomized controlled trial |
|
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 |