NCT03641300Completed
Efficacy of Convulsive Therapies for Bipolar Depression
Cognitive Outcomes and Response/Remission Efficacy of Convulsive Therapies for Bipolar Depression: the CORRECT-BD Trial
Source: ClinicalTrials.gov · Last updated 4 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This trial aims to assess the efficacy and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Bipolar Disorder (BD). Research indicates that the prevalence of treatment resistance in bipolar depression is twice that of unipolar depression. The limited effectiveness of current treatments for bipolar depression coupled with the medical and economic burden associated with the disorder engenders a need for novel therapeutic interventions that can provide greater response and remission rates.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 17 Aug 2018
- Start date
- 21 Sept 2018
- Primary completion date
- 4 Mar 2024
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Bipolar disorder
- NCT number
- NCT03641300
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 21 Sept 2018 to the primary completion date, 4 Mar 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- have a concomitant major unstable medical illness;
- have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;
- require a benzodiazepine with a dose greater than lorazepam 2 mg/day (or equivalent benzodiazepine) or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;
Other illness
- have a history of MINI diagnosis of substance dependence or abuse within the past three months;
- have a MINI diagnosis of any primary psychotic disorder
- have a MINI diagnosis of obsessive compulsive disorder, or post-traumatic stress disorder deemed to be primary and causing more functional impairment than the depressive disorder
- have probable dementia based on study investigator assessment;
- have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;
- have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
- These eligibility criteria are congruent with the criteria that have been used in the major ECT trials conducted during the past decade;
Lab values
- present with a medical condition, a medication, or a laboratory abnormality that could cause a major depressive episode or significant cognitive impairment in the opinion of the investigator (e.g., hypothyroidism with low TSH, rheumatoid arthritis requiring high dose prednisone, or Cushing's disease);
Other
- Patients will be excluded if they:
- are pregnant or intend to get pregnant during the study;
- are unable to communicate in English fluently enough to complete the neuropsychological tests;
- elevated mood, defined as a score of 20 or higher on the Young Mania Rating Scale (YMRS).
Who the study is looking for
- Patients will be included if they:
- are inpatients or outpatients;
- are voluntary and competent to consent to treatment and research procedures according to ECT/MST attending psychiatrist;
- have a MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0) diagnosis of non-psychotic Bipolar Disorder (Type I or II)
- are 18 years of age or older
- have a baseline HRSD-24 score \> 21;
- are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist
- are agreeable to keeping their current antidepressant treatment constant during the intervention;
- are likely able to adhere to the intervention schedule;
- meet the MST safety criteria;
- If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| UBC Hospital, University of British Columbia (UBC) Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Ontario Shores Centre for Mental Health Sciences Coordinator of this site? Confirm its status | Whitby | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.