At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 38 enrolled

Drug / intervention

sertraline +3 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00835627

NCT00835627Phase 4Completed

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Medication and Psychotherapy Treatment Trial for Psychogenic Nonepileptic Seizures

Rhode Island Hospital·interventional·Posted Feb 3, 2009·Updated Nov 10, 2014

In Brief

A Phase 4 clinical trial evaluating sertraline, CBT-ip, and 2 other interventions for Convulsion, Non-Epileptic and 4 related conditions. Completed, enrolled 38 participants across 3 sites.

Detailed Summary

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsConvulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Dissociative Disorders

CountriesUnited States

CollaboratorsAmerican Epilepsy Society, Epilepsy Foundation, University of Cincinnati, Stanford University

Timeline

Phase 4CompletedFinished

200920102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartSep 2008

First PostedFeb 2009

Primary CompletionDec 2012

Study CompletionJun 2013

TodayJul 2026

First PostedFeb 3, 2009

Enrollment StartSep 1, 2008

Primary CompletionDec 1, 2012

Study CompletionJun 1, 2013

TodayJul 2, 2026

Enrollment to primary: 4.3 yearsPosted 17.4 years ago

Interventions

sertralinedrug

flexible dose sertraline

CBT-ipbehavioral

cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: 12 individual 1 hour therapy sessions

Combined (sertraline + CBT-ip)other

flexible dose sertraline and cognitive behavioral therapy-informed psychotherapy for nonepileptic seizures: flexible dose sertraline and 12, individual 1 hour therapy sessions

Standard Careother

community care, treatment as usual: routine follow up with existing providers