Topics

Treatment Trial for Psychogenic Nonepileptic Seizures

2014-08-27 03:24:38 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Convulsion, Non-Epileptic

Intervention

sertraline, CBT for NES, Med+CBT, Standard Care

Location

Rhode Island Hospital
Providence
Rhode Island
United States
02903

Status

Recruiting

Source

Rhode Island Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:38-0400

Clinical Trials [1235 Associated Clinical Trials listed on BioPortfolio]

Treatments for Psychogenic Nonepileptic Seizures (NES)

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 ...

Treatment Outcomes of CBT-PNES

This research study is examining the effects of a cognitive behavioral intervention (an intervention focused on changing behaviors and thoughts) for psychogenic non-epileptic seizures (PNE...

Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

In this study patients will be randomized 1:2 to receive either standard of care treatment or standard of care + Sertraline 200mg/day for 2 weeks, then 400 mg/day for 50 weeks for treatmen...

A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety...

Using sEMG to Differentiate PNES From Epileptic Motor Seizures

This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurologi...

PubMed Articles [14104 Associated PubMed Articles listed on BioPortfolio]

Stereoselective separation of (1S, 4S)-sertraline from medicinal reaction mixtures by countercurrent chromatography with hydroxypropyl-β-cyclodextrin as stereoselective selector.

Four stereoisomeric components were produced during the synthesis of the antidepressant drug (1S,4S)-sertraline hydrochloride due to the two chiral carbon centers in its chemical structure, including ...

Emergency management and medical care of adults with first epileptic seizures.

Suspected epileptic seizures are a frequent cause of emergency hospital care. After single seizures, the emergency management includes safety measures and diagnostic efforts to distinguish epileptic s...

Efficacy of sertraline for post-stroke depression: A systematic review protocol of randomized controlled trial.

Depression is a prevalent disorder for patients with stroke. Clinical researches indicate that sertraline is utilized to treat post-stroke depression (PSD) effectively. However, no systematic review h...

Sertraline Effects on Striatal Resting-State Functional Connectivity in Youth With OCD: A Pilot Study.

Foundational knowledge on neural circuitry underlying pediatric obsessive-compulsive disorder (OCD) and how it changes during standard treatment is needed to provide the basis for conceptualization an...

The influence of sertraline on depressive disorder after traumatic brain injury: A meta-analysis of randomized controlled studies.

Sertraline showed some potential in alleviating depressive disorder after traumatic brain injury. This systematic review and meta-analysis was conducted to investigate the efficacy of sertraline on th...

Medical and Biotech [MESH] Definitions

EPILEPTIC SEIZURES that are of similar type and age of onset and have other similar features (e.g., clinical course, EEG findings, genetic association and neuropathology).

The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.

A selective serotonin uptake inhibitor that is used in the treatment of depression.

Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.

Medical care provided after the regular practice schedule of the physicians. Usually it is designed to deliver 24-hour-a-day and 365-day-a-year patient care coverage for emergencies, triage, pediatric care, or hospice care.

More From BioPortfolio on "Treatment Trial for Psychogenic Nonepileptic Seizures"

Quick Search

Relevant Topics

Depression
Depression is a serious mental health condition, where sad feelings carry on for weeks or months and interfere with your life. The symptoms include feeling unhappy most of the time (but may feel a little better in the evenings), loosing interest in lif...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...


Searches Linking to this Trial