Efficacy of Convulsive Therapies for Bipolar Depression

NACompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

September 21, 2018

Primary Completion Date

March 4, 2024

Study Completion Date

August 9, 2024

Conditions
Bipolar DisorderBipolar DepressionBipolar I DisorderBipolar II Disorder
Interventions
DEVICE

Magnetic Seizure Therapy (MST)

"MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."

DEVICE

Electroconvulsive Therapy (ECT)

In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes

Trial Locations (3)

V6T2A1

UBC Hospital, University of British Columbia (UBC), Vancouver

M6J 1H4

Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto

L1N 5S9

Ontario Shores Centre for Mental Health Sciences, Whitby

All Listed Sponsors
collaborator

University of British Columbia

OTHER

collaborator

Ontario Shores Centre for Mental Health Sciences

OTHER

collaborator

Brain Canada

OTHER

lead

Centre for Addiction and Mental Health

OTHER

NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression | Biotech Hunter | Biotech Hunter