Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06096207 | DBS for Depression | PHASE1 | RECRUITING | 20 | — | — | Oct 18, 2023 | Oct 18, 2038 | Jun 4, 2026 | 1 | United States |
The MADRS is the Montgomery-Asberg Depression Rating Scale, which at 12 months will be the primary endpoint. The investigators hypothesize is that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on MADRS scores. Also, that at 12 months 50% of the patients will be responders.
| Arm | Type | Description |
|---|---|---|
| Discontinuation Phase Group 1 | EXPERIMENTAL | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
| Discontinuation Phase Group 2 | EXPERIMENTAL | Patients will be randomized into two groups for crossover treatment analysis of different parameter settings for six weeks. |
| Name | Type | Description |
|---|---|---|
| Medtronic SenSight Directional DBS lead | DEVICE | At the ninth month post DBS implantation, the participant will enter a discontinuation phase of a duration of 6 weeks. The device will be turned on and off without participants' knowledge. After 6 weeks, the device will be turned back on if it was off. Whether the stimulation is active or not, it will be double blinded. |
Inclusion Criteria: 1. Major Depression Disorder (MDD) or Bipolar Disorder (I /II) diagnosed by Structured Clinical Interview for DSM-V (SCID I/DSM-V) 2. Age 18 - 65 years. 3. 24-item Hamilton Depression Rating Scale (HDRS) score of at least 21 on the first 17 items and/or Montgomery-Asburg Depress...