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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05165394 | Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD | PHASE2 | COMPLETED | 93 | — | — | Nov 30, 2021 | Sep 13, 2023 | Jul 31, 2024 | 23 | United States, Puerto Rico |
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participant follows Placebo schedule (57 days) |
| Antidepressant | EXPERIMENTAL | Participant follows NBI-1065846 schedule (57 days) |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablets for oral administration |
| NBI-1065846 | DRUG | Tablets for oral administration |
Key Inclusion Criteria: Participants must meet all of the following key inclusion criteria: 1. Completed written informed consent. 2. Aged 18 to 65 years, inclusive, at the time of informed consent. 3. Primary diagnosis of MDD. 4. Participants must meet one of the following criteria: * must ha...