Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMichigan State University
About this trial
This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.
Male or female patients 18 to 90 years of age
Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
Disqualifiers
Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment
Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding
History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment
Implanted devices that make ECT unsafe
Trial design
Design model
Parallel
Treatments tested in this trial
Sigma-Stim
DeviceRight Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA.
RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)
Procedure/SurgeryPlease see description above
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)Experimental treatment 2 interventions
Group B: RUL ECT (Electroconvulsive Therapy)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Suicide Ideation - Self Report
Beck Scale for Suicide Ideation (SSI-Worst and SSI-Current) - self reported. Minimum score of 0, maximum score of 42. Lower score indicates a better outcome.
Time frame
Through study completion, an average of four weeks2
Suicide Ideation - Clinician Rated
Columbia Suicide Severity Rating Scale (C-SSRS) - clinician administered. Intensity of suicidal ideation: minimum score of 0, maximum score of 5. Lower score indicates a better outcome. Suicidal behavior not rated on a scale.
Time frame
Through study completion, an average of four weeksSecondary outcomes
1
Depression - Clinician Rated
Montgomery-Asberg Depression Rating Scale (MADRS) - clinician administered. Minimum score of 0, maximum score of 60. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeks2
Depression - Self Report
Patient Health Questionnaire (PHQ9) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeks3
Depression - Self Report
Quick Inventory of Depressive Symptomatology (QIDS-SR) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeksOther outcomes
1
Anxiety
Generalized Anxiety Disorder (GAD7) - self reported. Minimum score 0, maximum score 21. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeks2
Psychosis
Positive and Negative Syndrome Scale (PANSS) - clinician administered. Full scale minimum score of 31. Maximum score of 217. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeks3
Global Clinical Assessment
Clinical Global Improvement (CGI) - clinician administered. Severity: minimum score of 0, maximum score of 7, lower score indicates better outcome. Improvement: minimum score of 0, maximum score of 7, lower score indicates better outcome.
Time frame
Through study completion, an average of four weeks4
Time to Reorientation after ECT sessions
Time to Reorientation scale (TRO) - study staff administered. Minimum score 3 minutes, maximum score more than 20 minutes. Lower score indicates better outcome.
Time frame
Through study completion, an average of four weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michigan State University
Lead sponsor
Pine Rest Christian Mental Health Services
Collaborator
Source ClinicalTrials.gov