Bipolar Depression, Major Depressive Disorder
Conditions
Keywords
Magnetic Seizure Therapy, Electroconvulsive Therapy, Depression, Major Depressive Disorder, Bipolar Depression, Cognition
Brief summary
This study aims to compare the efficacy and safety profile of Magnetic Seizure Therapy and Electroconvulsive therapy.
Detailed description
Magnetic seizure therapy (MST) is a novel, experimental therapeutic intervention, which combines therapeutic aspects of electroconvulsive therapy (ECT) and transcranial magnetic stimulation, in order to achieve the efficacy of the former with the safety of the latter. While ECT remains the most efficacious treatment available for severe and treatment-resistant depression, it is hampered by its side effect profile, specially cognitive deficits, which albeit transitory might be particularly distressing for patient, not to mention the stigma that still clings to this method. MST employs high frequency magnetic pulses applied to the head to the patient in order to induce generalized epileptic activity, thus emulating the core feature of ECT. Though distributed over a large area, such pulses do not penetrate deeper areas of the brain, therefore sparing deeper areas such as the hippocampi, which are crucial for memory encoding. The goal of this study is to compare the antidepressant action and safety profile of MST to ECT, using a non-inferiority approach. It also aims to compare the cognitive side effects profile of both interventions, as well as investigate possible neuroimaging changes and response predictors before and after treatments.
Interventions
DEVICEMagnetic Seizure Therapy
Subjects will receive a train of magnetic pulses (between 600 and 1400 pulses) at 100Hz under general anaesthesia using a Magventure device with a Twin Coil
DEVICEElectroconvulsive Therapy
Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device
Sponsors
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients will be anaesthetised before the procedure, therefore will not be able to tell whether they received ECT ou MST. The preparation procedures before seizure will be identical for all participants regardless of the intervention. All monitoring and other procedures will be exactly the same for both groups. Investigator and rater will not have access to which procedure subjects received. To blind the staff, the MST sound will performed during all study interventions.
Intervention model description
Subjects will be randomly and blindly allocated to either of two interventions, namely, MST or ECT. Clinical and cognitive parameters will be assessedat baseline, weeks 6, 12 and 18.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Major Depressive Disorder or Bipolar Depression in accordance to the Diagnostic and Statistical Manual (DSM) criteria * Score equal to or great than 17 points on the Hamilton Depression Rating Scale * Treatment-resistant depression, defined as insufficient relief of symptoms after two different first line treatments using therapeutic doses and for four to six weeks * Adequate health and clinical conditions, as assessed by an anaesthesiologist and a psychiatrist
Exclusion criteria
* Pregnancy * Other psychiatric conditions such as Schizophrenia, Schizoaffective Disorder, Substance Abuse, Borderline Personality Disorder, PTSD, or Intellectual Deficiency * Depressive symptoms due to a clinical condition * Any clinical or neurological conditions without proper management * ECT or any other neuromodulation treatment on the last six months * Inability to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period. | Score on the 17 items Hamilton Depression Rating Scale (HDRS-17). It measures the severity of clinical symptoms, ranging from 0 to 52, with higher scores indicating greater severity. |
| Biographical memory | Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period. | Score on the Autobiographical Memory Inventory (AMI). Interviewer-rated measure with 10 items that indexes autobiographical memory recall and specificity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period. | Score on the Montgomery-Asberg Depression Rating Scale (MADRS). It measures the severity of clinical symptoms, ranging from 0 to 60, with higher scores indicating greater severity. |
| Suicidal Thoughts | Change from baseline to endpoint (week 18). However, the endpoint can be at week 12 if the patient is remitted at this time period. | Score on the Beck Scale for Suicidal Ideation (BSS). The BSS contains 19 items that measure the severity of actual suicidal wishes and plans. Scores range from 0 to 38, a higher score indicating a higher level of suicide ideation. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORANDRE R BRUNONI
FACULDADE DE MEDICINA DA USP
Outcome results
None listed