Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2003-12-31
2009-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
sertraline
flexible dose sertraline
placebo
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
placebo
flexible dose placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sertraline
flexible dose sertraline
placebo
flexible dose placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Rhode Island Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
W. Curt LaFrance Jr., M.D.
PI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
W. Curt LaFrance, Jr., MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rhode Island Hospital/Brown Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.