Phase 4
N=38
Treatments for Psychogenic Nonepileptic Seizures (NES)
Convulsion, Non-Epileptic · Conversion Disorder · Depression · Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT00159965 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jan 2011
Primary outcome: Primary: Number of Nonepileptic Seizures (NES) — 5.0; 6.0; 3.0; 6.0 seizures — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- sertraline (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rhode Island Hospital
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Nonepileptic Seizures (NES) |
5.0; 6.0; 3.0; 6.0; 2.0; 5.0 | 0.29 |
| SECONDARY Beck Depression Inventory-II (BDI-II) |
16.7; 22.1; 11.7; 17.0 | >0.05 |
| SECONDARY Modified Hamilton Depression Scale (MHRS) |
17.8; 16.8; 11.6; 13.3 | >0.05 |
| SECONDARY Global Assessment of Functioning (GAF) |
53.3; 49.1; 56.8; 52.0 | >0.05 |
| SECONDARY Davidson Trauma Scale (DTS) |
52.5; 48.1; 40.3; 43.4 | >0.05 |
| SECONDARY Barratt Impulsivity Scale (BIS) |
57.8; 72.6; 64.9; 66.2 | >0.05 |
| SECONDARY Dissociative Experiences Scale (DES) |
21.0; 17.4; 8.5; 12.1 | >0.05 |
| SECONDARY Symptom Checklist 90 (SCL-90) |
84.9; 109.4; 78.9; 91.4 | >0.05 |
| SECONDARY Oxford Handicap Scale (OHS) |
3.1; 3.4; 2.3; 2.6 | >0.05 |
| SECONDARY Clinical Global Impressions - Severity (CGI-S) |
4.9; 5.1; 3.3; 3.9 | >0.05 |
| SECONDARY Clinical Global Impressions - Improvement (CGI-I) |
2.9; 3.5 | >0.05 |
| SECONDARY Family Assessment Device (FAD) |
2.0; 2.0; 2.0; 2.2 | >0.05 |
| SECONDARY Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT) |
11.8; 13.9; 11.8; 13.8 | >0.05 |
| SECONDARY Quality of Life in Epilepsy-31 (QOLIE-31) |
48.4; 38.2; 56.7; 46.9 | >0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Video electroencephalogram (vEEG) confirmed diagnosis of NES
- 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
- Equivocal electroencephalogram (EEG) findings
- 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
Data sourced from ClinicalTrials.gov (NCT00159965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.