Electroconvulsive Therapy, Intravenous Ketamine, Major Depressive Disorder, Treatment-Resistant
Conditions
Brief summary
This study aimed to compare the efficacy, safety, and tolerability of electroconvulsive therapy (ECT) versus intravenous (IV) ketamine in adults with treatment-resistant major depressive disorder (TRD).
Detailed description
Treatment resistant depression is defined as a lack of adequate response to at least two antidepressant trials of sufficient dose, duration, and adherence in the current depressive episode. Recent studies estimate treatment-resistant depression (TRD) by 30% of people with major depressive disorder (MDD) leading to significant challenges in care. This condition can increase disability, healthcare costs, and suicide risk, making effective treatments crucial.
Interventions
DRUGElectroconvulsive Therapy
Patients received Bitemporal electroconvulsive Therapy (ECT) (2x/week for 4 weeks).
DRUGKetamine
Patients received intravenous (IV) ketamine 0.5 mg/kg IV infusion over 40 mins (2x/week for 4 weeks).
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-75 years. * Current diagnosis of major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. * Treatment resistance defined as failure to respond to ≥2 adequate antidepressant trials in the current episode. * Montgomery-Åsberg Depression Rating Scale (MADRS) score ≥20. * Capacity to provide informed consent.
Exclusion criteria
* History of psychotic disorders or bipolar disorder. * Current substance use disorder. * Significant neurological disorders or traumatic brain injury. * Uncontrolled hyper- tension. * cardiovascular diseases in the past six months. * Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montgomery-Åsberg Depression Rating Scale | 3 weeks post-procedure | Change in Montgomery-Åsberg Depression Rating Scale (MADRS) was recorded from baseline to end of 3-week treatment period. The MADRS comprises the following 10 items: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; and (10) suicidal thoughts. With a, maximum score of 60, where higher scores indicate greater severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) | 3 weeks post-procedure | Montreal Cognitive Assessment (MoCA) for cognitive function was recorded from baseline to end of 3-week treatment period. MoCA is a rapid, 10-15 minute screening tool used to detect mild cognitive impairment (MCI) and early dementia, scoring a maximum of 30 points, with a score of 26 or higher considered normal. |
| Patient Health Questionnaire-9 (PHQ-9) | 3 weeks post-procedure | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item, self-administered diagnostic tool used by clinicians to screen for the presence and severity of depression. It assesses symptoms over the past two weeks based on DSM-IV criteria, with scores ranging from 0 to 27, where higher scores indicate greater depression severity. |
Countries
Egypt
Outcome results
None listed