A Phase 4 interventional study of sertraline and placebo in Convulsion, Non-Epileptic, Conversion Disorder and Depression, sponsored by Rhode Island Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2014-11-20.
Sponsored by Rhode Island Hospital · Phase 4, Interventional, and Treatment
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.
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.
881 studies on the registry are indexed under Seizures; 143 are open to participants now.
This study's enrollment of 38 is below the median of 64 across 610 interventional studies indexed under Seizures.
Browse Seizures studies →Rhode Island Hospital is the lead sponsor of 187 studies on the registry; 37 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: sertraline
flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Drug: placebo
flexible dose sertraline
Also known as: Zoloft
flexible dose placebo
Number of Nonepileptic Seizures (NES)
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
Time frame: bi-weekly at baseline and weeks 2, 4, 6, 8, 10, 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: Baseline and weeks 2, 6, 10 (total time frame of 12 weeks)
Patients were referred to the Rhode Island Hospital (RIH) neuropsychiatry/behavioral neurology clinic between July 2002 and June 2008, after being diagnosed with psychogenic nonepileptic seizures (PNES). PNES diagnosis was established by capturing at least one of the patient's typical PNES on video electroencephalogram (vEEG).
| Milestone | Sertraline | Placebo |
|---|---|---|
| Started | 19 | 19 |
| Completed | 12 | 14 |
| Not completed | 7 | 5 |
psychogenic nonepileptic seizure (NES) frequency, collected prospectively, using a daily seizure calendar; aggregated into biweekly intervals.
| seizures | Sertraline | Placebo |
|---|---|---|
| Baseline (retrospective 2 weeks prior) | 5.0 ± 43.5 | 6.0 ± 12.1 |
| Week 2 (prospectively collected from day 1-14) | 3.0 ± 37.7 | 6.0 ± 8.5 |
| Week 4 | 2.0 ± 31.5 | 5.0 ± 10.6 |
| Week 6 | 1.0 ± 31.5 | 3.0 ± 16.4 |
| Week 8 | 1.0 ± 24.4 | 3.0 ± 17.4 |
| Week 10 | 2.5 ± 30.7 | 7.0 ± 12.4 |
| Week 12 | 0.0 ± 20.3 | 6.0 ± 14.0 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 16.7 ± 13.0 | 22.1 ± 13.9 |
| Exit | 11.7 ± 11.5 | 17.0 ± 13.3 |
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.
| units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 17.8 ± 21.0 | 16.8 ± 8.8 |
| Exit | 11.6 ± 9.0 | 13.3 ± 8.4 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 53.3 ± 10.3 | 49.1 ± 7.1 |
| Exit | 56.8 ± 11.0 | 52.0 ± 7.9 |
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.
| units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 52.5 ± 31.6 | 48.1 ± 40.0 |
| Exit | 40.3 ± 36.9 | 43.4 ± 40.0 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 57.8 ± 16.5 | 72.6 ± 17.8 |
| Exit | 64.9 ± 13.2 | 66.2 ± 15.9 |
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.
| units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 21.0 ± 19.7 | 17.4 ± 11.0 |
| Exit | 8.5 ± 13.2 | 12.1 ± 12.2 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 84.9 ± 73.3 | 109.4 ± 70.9 |
| Exit | 78.9 ± 67.2 | 91.4 ± 77.2 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 3.1 ± 0.8 | 3.4 ± 0.7 |
| Exit | 2.3 ± 1.3 | 2.6 ± 1.2 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 4.9 ± 0.8 | 5.1 ± 0.6 |
| Exit | 3.3 ± 1.6 | 3.9 ± 0.9 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Clinical Global Impressions - Improvement (CGI-I) | 2.9 ± 1.4 | 3.5 ± 1.6 |
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.
| General Functioning Subscale Score | Sertraline | Placebo |
|---|---|---|
| Baseline | 2.0 ± 0.7 | 2.0 ± 0.5 |
| Exit | 2.0 ± 0.6 | 2.2 ± 0.5 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 11.8 ± 3.6 | 13.9 ± 3.8 |
| Exit | 11.8 ± 4.8 | 13.8 ± 3.3 |
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.
| Units on a scale | Sertraline | Placebo |
|---|---|---|
| Baseline | 48.4 ± 20.7 | 38.2 ± 19.0 |
| Exit | 56.7 ± 25.1 | 46.9 ± 24.0 |
Collected over 12 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sertraline | — | 0/19 (0%) | 1/19 (5.3%) |
| Placebo | — | 0/19 (0%) | 4/19 (21.1%) |
| Event | Sertraline | Placebo |
|---|---|---|
| tiredness/ sleepinessNervous system disorders | 1/19 | 4/19 |
| Age, Categorical(Participants) | Sertraline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 19 | 38 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Sertraline | Placebo | Total |
|---|---|---|---|
| Mean | 38 ± 13.9 | 34.4 ± 12.6 | 36.2 ± 13.2 |
| Sex: Female, Male(Participants) | Sertraline | Placebo | Total |
|---|---|---|---|
| Female | 16 | 13 | 29 |
| Male | 3 | 6 | 9 |
| Region of Enrollment(participants) | Sertraline | Placebo | Total |
|---|---|---|---|
| United States | 19 | 19 | 38 |
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