PD, PK, and Safety of ALTO-203 in Patients With MDD
Purpose
The goal of this clinical trial is to determine the pharmacodynamic effects of ALTO-203 in patients with MDD in a randomized, placebo-controlled, single-dose crossover treatment period. Additionally, safety, tolerability, and PK will be assessed in a subsequent randomized placebo-controlled multi-dose parallel-group treatment period of 28 days. Participants will complete subjective response questionnaires and perform cognitive tasks during the single-dose period, in which participants will receive ALTO-203 25 μg and 75 μg, as well as placebo. During the multiple-dose period, participants will receive either ALTO-203 25 μg, 75 μg , or placebo. Safety will be assessed over the single dose and 28-day multiple dose periods.
Conditions
- Major Depressive Disorder
- Anhedonia
Eligibility
- Eligible Ages
- Between 25 Years and 64 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 - Diagnosed bipolar disorder, psychotic disorder, or dementia - Concurrent use of prohibited medications - Current moderate or severe substance use disorder - Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- The study will consist of two treatment periods. The initial Single-Dose Treatment Period is a randomized, double-blind, placebo-controlled 3-way crossover design with oral administration of a single dose of ALTO-203 25 μg, ALTO-203 75 μg, and matching placebo. In the subsequent Multi-Dose Parallel-Group Treatment Period, participants will receive ALTO-203 25 μg, ALTO-203 75 μg, or matching placebo randomized 1:1:1 for a total of 28 days.
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ALTO-203 25 μg |
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 |
|
|
Experimental ALTO-203 75 μg |
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 Comparator Placebo |
Drug: Placebo Single-Dose Treatment Period: Single Dose, Placebo Multi-Dose Treatment Period: Placebo, administered orally, once daily for 28 days |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Alto Neuroscience
