Mental and Behavioural Disorders
Conditions
Interventions
Deep Brain Stimulation
No Stimulation DBS device deactivated.
Sponsors
Neuroad Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age range of 18- 50 years Diagnosed with Major Depressive Disorder according to DSM-5 or TR criteria. Documented history of Treatment Resistant Depression defined as failing to achieve adequate symptom remission after at least two different medication trials at appropriate dosages and durations. Medically and neurologically healthy with no significant medical condition PHQ-9 score of > 15 at both baseline and screening visits. Presence of variability in depression rating scales (minimum of 2-point variation on the HAMD-6 administered 3 times a day for 3 days) for neural biomarker identification. Stable regimen of psychotropic medication with no changes for at least 4 weeks prior to study entry and throughout the study duration. Able to provide a written informed consent and accept to adhere to study procedures.
Exclusion criteria
Exclusion criteria: Patient meeting DSM-V criteria for a psychotic disorder, eating disorder, panic disorder, posttraumatic stress disorder, bipolar disorder, obsessive-compulsive disorder, tic disorder, or another comorbid psychiatric disorder other than MDD or generalized anxiety disorder. Active suicidal ideation with intent or plan, as defined by a score of 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS). Meets criteria for alcohol or substance abuse or dependence (other than caffeine) in the previous 6 months, determined by the SCID. History of severe substance abuse or dependence. Uncontrolled medical illness (e.g., uncontrolled epilepsy, significant cardiac disease). Major neurological disorders (e.g., dementia, active brain tumor). Pregnant women or those not willingness to use effective contraception during the study and breastfeeding women Inability to undergo MRI scans due to claustrophobia or incompatible medical implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Depression score using PHQ-9 score Effect size of active compared to sham stimulation or no stimulation (mean difference in Patient health Questionnaire score before and after each arm period). Higher PHQ-9 score indicates more severe depression; the overall score ranges from 0 to 27. Difference in Hamilton Depression Rating Scale (HDRS-17) score Mean difference in Hamilton Depression Rating Scale (HDRS-17) score across the two 6-week cross-over periods. The score for Hamilton Depression Rating Scale ranges from 0-50, with a higher score indicating more severe depression. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability of DBS Measurement: Monitoring for adverse events (e.g., cognitive side effects, mood changes, motor disturbances). Time Points: Continuous during all phases, including post-surgery and follow-up assessments. Biomarkers of Depression (Cortisol Levels) Measurement: Cortisol concentration in biological samples. Time Points: Baseline, end of each intervention cycle, and quarterly during follow-up. Functional and Quality of Life Assessments Measurement: Clinician and self-reported measures of functional ability and quality of life. Time Points: Baseline and quarterly follow-ups for 5 years | — |
Countries
Rwanda
Contacts
Public ContactJean Damascene Bigirimana
Public health Specialist
Outcome results
None listed