Efficacy of Convulsive Therapies During Continuation

Status Recruiting

Clinical Trial Summary

This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) and two different forms of electroconvulsive therapy (ECT) in sustaining response during and after a course of continuation treatment.

Clinical Trial Description

The study will involve a parallel-group clinical trial with three treatment arms conducted at the Centre for Addiction and Mental Health (CAMH) in Toronto, ON, Ontario Shores Centre for Mental Health Sciences in Whitby, ON and University of British Columbia (UBC) Hospital in Vancouver, BC. It will include participants who are classified as responders or remitters in the CREST-MST (NCT03191058) trial, the CORRECT-BD (NCT03641300) trial and individuals responding to bitemporal ECT after participating in either of the above trials, who qualify for a continuation course of convulsive therapy to prevent relapse of depression. Individuals blinded to their acute course of treatment will continue to receive the convulsive therapy to which they responded in in a blinded fashion. Continuation treatments will be scheduled according to a modified version of the Symptom-Titrated Algorithm-based Longitudinal ECT (STABLE) algorithm. STABLE includes an initial four week period of ECT delivered on a fixed schedule (once or twice per week), and then transitions to a symptom-driven schedule whereby ECT is delivered between zero and two times per week based on the patient's weekly Hamilton Rating Scale for Depression (HRSD-24) outcomes during weeks five to 24. Further, this trial will also include non-responders to MST or right unilateral ultrabrief pulse ECT (RUL-UB ECT) from CREST-MST or CORRECT-BD, who are switched to bitemporal ECT based on their clinical indication. They will receive bitemporal ECT on an acute basis, i.e. 2 - 3 times per week. If their symptoms respond or remit with bitemporal ECT, they will also be offered a continuation course of bitemporal ECT as part of this trial and will be followed in the same manner as those receiving MST or RUL-UB ECT. ;

Study Design

Related Conditions & MeSH terms

Bipolar Depression
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Treatment Resistant Depression
Unipolar Depression

Clinical Trial Details

NCT number	NCT03711019
Study type	Interventional
Source	Centre for Addiction and Mental Health
Contact	Daniel Blumberger, MD, MSc
Phone	416-535-8501
Email	daniel.blumberger@camh.ca
Status	Recruiting
Phase	N/A
Start date	October 22, 2018
Completion date	September 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Efficacy of Convulsive Therapies During Continuation — CORRECT-C

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms