Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159965
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2005-09-08
Brief Title:
Treatments for Psychogenic Nonepileptic Seizures NES
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NES
Brief Summary:
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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23NS045902 | NIH | None | httpsreporternihgovquickSearch5K23NS045902 |