Convulsion, Non-EpilepticPhase 4NESNCT00159965
Treatments for Psychogenic Nonepileptic Seizures (NES)
A Phase 4 study testing sertraline in people with Convulsion, Non-Epileptic and Conversion Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Convulsion, Non-Epileptic, Conversion Disorder, Depression
- What is being tested?
- sertraline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jun 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES
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.
Read the detailed description
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 R01, 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 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
- Convulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic
- Being tested
- sertraline, placebo
- Keywords
- nonepileptic seizure, pseudoseizure, conversion disorder, psychogenic, Depression, Anxiety, Abuse, post-traumatic stress disorder, sertraline, serotonin, randomized controlled trial
- Medical subject headings
- Seizures, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic, Psychogenic Nonepileptic Seizures, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
Also called Zoloft
flexible dose sertraline
placeboDrug
flexible dose placebo
| Study group | Role | What they receive |
|---|---|---|
| sertraline | Active comparator | 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 Receives: Drug: sertraline |
| placebo | Placebo comparator | flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Nonepileptic Seizures (NES)
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
Measured: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
Secondary outcomes (13)
Beck Depression Inventory-II (BDI-II)
The BDI-II assesses depression severity from "0" (no Depression-related symptom) to "3" (severe) on each question. The highest possible score is "51", relating to the worst outcome.
Measured: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
Modified Hamilton Depression Scale (MHRS)
The MHRS assesses the severity of Depression-related symptoms from "0" (not present) to "2", "3" or "4" (severe) on each question. The highest possible score is "72", relating to the worst outcome.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Global Assessment of Functioning (GAF)
This GAF rating scale ranges from 0 (worst) to 100 (best) and is used for evaluating the overall functioning of a subject during a specified time period on a continuum from psychological or psychiatric sickness to health.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Davidson Trauma Scale (DTS)
The DTS is a 17-item self-report scale measuring each Diagnostic and Stastical Manual of Mental Disorders-4th Edition (DSM-IV) symptom of post-traumatic stress disorder (PTSD) on 5-point frequency (0-not at all to 4-everyday) and severity (0-not at all distressing to 4-extremely distressing) scales. The highest possible score is 136 and relates to the worst outcome.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Barratt Impulsivity Scale (BIS)
The BIS is a 30 item self-report measure that characterizes four aspects of impulsiveness, and ranges from "rarely/ never" to "almost always" with a score of "1" to "4" possible on each question, giving a maximum possible score of 120 and minimum possible score of 30. Selected questions are reversed scored. Higher scores relate to a worse outcome.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Dissociative Experiences Scale (DES)
The DES is a 28 item self-report questionnaire designed to quantify dissociative experiences which identifies disturbances in memory, identity, cognition, derealization, depersonalization, absorption and imagination. A visual analogue scale is used ranging from 0% ("This never happens to you") to 100% ("This always happens to you"). The score is divided by 28 items to yield a range of 0 to 100%, with a higher score relating to a higher degree of dissociation.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Symptom Checklist 90 (SCL-90)
The SCL-90 is a 90 item self-report clinical rating scale oriented toward symptomatic behavior of outpatients, assessing from "0" (not at all bothered) to "4" (extremely bothered). The highest possible overall score is 360 and relates to a worse outcome.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Oxford Handicap Scale (OHS)
The OHS is a brief clinician scored assessment of symptoms and lifestyle interference and the 6 grades of disability are based on the modified Rankin Scale, ranging from "0" (no symptoms) to "5" (severe handicap). A higher score relates to a worse outcome.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Clinical Global Impressions - Severity (CGI-S)
The CGI-S is the first item of a two-item global rating scale, where each item is on a 7 point scale ranging from normal ("1") to among the most extremely ill patients ("7"). A higher score relates to a higher severity of illness.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Clinical Global Impressions - Improvement (CGI-I)
The CGI-I is the second item of a two item global rating scale, where each item is on a 7 point scale ranging from very much improved ("1") to very much worse ("7"). A lower score represents a higher improvement.
Measured: Weeks 2, 6, 10
Family Assessment Device (FAD)
The FAD is a 60 item self-report questionnaire designed to assess the six dimensions of the McMaster Model of Family Functioning, as well as overall level of family functioning through the General Functioning Scale. Each question is scored on a "1" to "4" scale, with a higher mean score relating to a worse general functioning.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
The LIFE-RIFT interview is a brief semi-structured interview, which measures functional impairment, targeting four domains: work, interpersonal relations, recreation and global satisfaction. Work, recreation and global satisfaction are rated on a "1" (very good/ no impairment) to "5" (very poor/ severe impairment) scale, and interpersonal relations is rated on a "1" (very good) to "7" (variable) scale. The highest score possible is 20 and relates to a more severe impairment. The lowest possible score is 3.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Quality of Life in Epilepsy-31 (QOLIE-31)
This is a 31-item self-report scale used in the seizure population to evaluate Quality of Life. The lowest possible score is 0 and the highest possible score is 100, reflecting a better quality of life.
Measured: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionJun 2008
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Convulsion, Non-EpilepticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Curt LaFrance Jr., M.D., Rhode Island Hospital
- Investigators
- W. Curt LaFrance, Jr., MD, MPH, Principal investigator, Rhode Island Hospital/Brown Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159965
- Sponsor's protocol ID
- 5K23NS045902-05
- Other IDs
- 5K23NS045902
- Acronym
- NES
- Status last verified
- Nov 2014
- First submitted
- 8 Sep 2005
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.
PubMed 15186340LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. doi: 10.1212/wnl.58.6.990. No abstract available.
PubMed 11914432LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.
PubMed 16540377LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.
PubMed 16150653LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. doi: 10.1016/j.yebeh.2007.12.017. Epub 2008 Feb 20.
PubMed 18282812LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.
PubMed 18317280LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. doi: 10.1016/s1525-5069(02)00505-4.
PubMed 12609316LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. doi: 10.1212/01.wnl.0000224953.94807.be. No abstract available.
PubMed 16769930LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.
PubMed 18070841LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.
PubMed 19652140LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
PubMed 20739647
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Psychogenic Nonepileptic Seizures: A Pilot, 12 Week, Prospective, Randomized, Placebo-controlled, Double-blind, Clinical Trial of Sertraline in the Treatment of Comorbid Psychiatric Disorders in NES
- ClinicalTrials.gov ID
- NCT00159965
- Acronym / sponsor ID
- NES / 5K23NS045902-05
- Conditions
- Convulsion, Non-Epileptic, Conversion Disorder, Depression, Stress Disorders, Post-Traumatic
- Keywords
- nonepileptic seizure, pseudoseizure, conversion disorder, psychogenic, Depression, Anxiety, Abuse, post-traumatic stress disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Dec 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Posted 25 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 R01, 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sertraline | Active comparator | Drug: sertralineflexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES |
| placebo | Placebo comparator | Drug: placeboflexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sertralineAlso: Zoloftflexible dose sertraline | Drug | sertraline |
| placeboflexible dose placebo | Drug | placebo |
Primary outcome
Number of Nonepileptic Seizures (NES)
Time frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
13 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
Modified Hamilton Depression Scale (MHRS)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Global Assessment of Functioning (GAF)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Davidson Trauma Scale (DTS)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Barratt Impulsivity Scale (BIS)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Dissociative Experiences Scale (DES)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Symptom Checklist 90 (SCL-90)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Oxford Handicap Scale (OHS)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Clinical Global Impressions - Severity (CGI-S)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Clinical Global Impressions - Improvement (CGI-I)
Time frame: Weeks 2, 6, 10
Family Assessment Device (FAD)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Longitudinal Interval Follow-Up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Quality of Life in Epilepsy-31 (QOLIE-31)
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15186340LaFrance WC Jr, Devinsky O. The treatment of nonepileptic seizures: historical perspectives and future directions. Epilepsia. 2004;45 Suppl 2:15-21. doi: 10.1111/j.0013-9580.2004.452002.x.
- Background: PubMed 11914432LaFrance WC. How many patients with psychogenic nonepileptic seizures also have epilepsy? Neurology. 2002 Mar 26;58(6):990; author reply 990-1. doi: 10.1212/wnl.58.6.990. No abstract available.
- Background: PubMed 16540377LaFrance WC Jr, Alper K, Babcock D, Barry JJ, Benbadis S, Caplan R, Gates J, Jacobs M, Kanner A, Martin R, Rundhaugen L, Stewart R, Vert C; NES Treatment Workshop participants. Nonepileptic seizures treatment workshop summary. Epilepsy Behav. 2006 May;8(3):451-61. doi: 10.1016/j.yebeh.2006.02.004. Epub 2006 Mar 15.
- Background: PubMed 16150653LaFrance WC Jr, Barry JJ. Update on treatments of psychological nonepileptic seizures. Epilepsy Behav. 2005 Nov;7(3):364-74. doi: 10.1016/j.yebeh.2005.07.010. Epub 2005 Sep 16.
- Background: PubMed 18282812LaFrance WC Jr, Rusch MD, Machan JT. What is "treatment as usual" for nonepileptic seizures? Epilepsy Behav. 2008 Apr;12(3):388-94. doi: 10.1016/j.yebeh.2007.12.017. Epub 2008 Feb 20.
- Background: PubMed 18317280LaFrance WC Jr. Psychogenic nonepileptic seizures. Curr Opin Neurol. 2008 Apr;21(2):195-201. doi: 10.1097/WCO.0b013e3282f7008f.
- Background: PubMed 12609316LaFrance WC Jr, Devinsky O. Treatment of nonepileptic seizures. Epilepsy Behav. 2002 Oct;3(5 Suppl):19-23. doi: 10.1016/s1525-5069(02)00505-4.
- Background: PubMed 16769930LaFrance WC Jr, Benbadis SR. Avoiding the costs of unrecognized psychological nonepileptic seizures. Neurology. 2006 Jun 13;66(11):1620-1. doi: 10.1212/01.wnl.0000224953.94807.be. No abstract available.
- Results publication: PubMed 18070841LaFrance WC Jr, Blum AS, Miller IW, Ryan CE, Keitner GI. Methodological issues in conducting treatment trials for psychological nonepileptic seizures. J Neuropsychiatry Clin Neurosci. 2007 Fall;19(4):391-8. doi: 10.1176/jnp.2007.19.4.391.
- Results publication: PubMed 19652140LaFrance WC Jr, Syc S. Depression and symptoms affect quality of life in psychogenic nonepileptic seizures. Neurology. 2009 Aug 4;73(5):366-71. doi: 10.1212/WNL.0b013e3181b04c83.
- Results publication: PubMed 20739647LaFrance WC Jr, Keitner GI, Papandonatos GD, Blum AS, Machan JT, Ryan CE, Miller IW. Pilot pharmacologic randomized controlled trial for psychogenic nonepileptic seizures. Neurology. 2010 Sep 28;75(13):1166-73. doi: 10.1212/WNL.0b013e3181f4d5a9. Epub 2010 Aug 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W. Curt LaFrance, Jr., MD, MPH principal investigator
Rhode Island Hospital/Brown Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sertraline in people with Convulsion, Non-Epileptic and Conversion Disorder, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Nonepileptic Seizures (NES) (time frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00159965, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.