We propose that treatment of the comorbid disorders (depression, anxiety, and impulsivity) with sertraline in patients with lone nonepileptic seizures (NES), will result in 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 Sertraline	Drug: sertraline	Phase IV

Further Study Details: 

Primary Outcomes: Number of NES
Secondary Outcomes: identify predictors of response from the following 3 groups:; clinical diagnoses; psychological symptoms; socio-demographic variables
Expected Total Enrollment:  50

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 RO1, multi-center randomized control trial. Secondary objective variables include reduc-tion in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.

After being diagnosed with NES by video EEG monitoring (vEEG), 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 neu-rological exam, and with bi-weekly, 30 to 60 minute appointments where they will com-plete 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.

Ages Eligible for Study:  18 Years   -   95 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• video EEG confirmed diagnosis of NES
• have at least one nonepileptic seizure per month
• comorbid diagnosis of either depression, anxiety, or PTSD
• able to complete self report symptom scales
• not receiving optimized antidepressant medication

Exclusion Criteria:

• equivocal EEG findings
• current suicidality, litigation, or self-mutilation
• using MAOIs, pimozide, or sumatriptan
• allergy/sensitivity to sertraline
• current alcohol/drug dependence
• serious medical illness requiring current hospitalization

Please refer to this study by ClinicalTrials.gov identifier  NCT00159965

W. Curt LaFrance, Jr., MD      401-444-3534    William_LaFrance_Jr@Brown.edu
Jackie Albro      401-444-3946    JAlbro@lifespan.org

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting

Study chairs or principal investigators

W. Curt LaFrance, Jr., MD,  Principal Investigator,  Rhode Island Hospital / Brown Medical School   

Study ID Numbers:  5K23 NS 045902-03
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159965
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13