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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06391593 | PD, PK, and Safety of ALTO-203 in Patients With MDD | PHASE2 | COMPLETED | 69 | — | — | Mar 25, 2024 | Apr 21, 2025 | Apr 17, 2026 | 15 | United States |
The Bond-Lader Visual Analogue Scale (BL-VAS) is used to measure the effects of drugs on the participants' mood. It consists of 16 VAS measurements of different mood state. For each question, the participants will rate their feelings at the time of assessment by indicating the point on the 10 cm line which best represents their mood. Each item is scored by measuring the position relative to the left-hand end of the line. The combined domains of alertness and mood will be assessed for the primary endpoint.
Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.
| Arm | Type | Description |
|---|---|---|
| ALTO-203 25 μg | EXPERIMENTAL | Drug: ALTO-203 25 μg Single-Dose Treatment Period: Single Dose, ALTO-203 25 μg Multi-Dose Treatment Period: ALTO-203 25 μg, administered orally, once daily for 28 days |
| ALTO-203 75 μg | EXPERIMENTAL | Drug: ALTO-203 75 μg Single-Dose Treatment Period: Single Dose, ALTO-203 75 μg Multi-Dose Treatment Period: ALTO-203 75 μg, administered orally, once daily for 28 days |
| Placebo | PLACEBO_COMPARATOR | Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days |
| Name | Type | Description |
|---|---|---|
| ALTO-203 25 μg | DRUG | Active, ALTO-203 25 μg |
| ALTO-203 75 μg | DRUG | Active, ALTO-203 75 μg |
| Placebo | DRUG | Comparator, Placebo-to-match |
Inclusion Criteria: * Have a diagnosis of moderate major depressive disorder (MDD) * Presence of anhedonia symptoms * Not taking antidepressant at Screening Visit 2 * Willing to comply with all study assessments and procedures Exclusion Criteria: * Evidence of unstable medical condition * Diagnos...