Anhedonia, Major Depressive Disorder
Conditions
Brief summary
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.
Interventions
DRUGALTO-203 25 μg
Active, ALTO-203 25 μg
DRUGALTO-203 75 μg
Active, ALTO-203 75 μg
DRUGPlacebo
Comparator, Placebo-to-match
Sponsors
Alto Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
25 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose Period: To evaluate pharmacodynamic measures in patients with MDD after single doses of 25 μg ALTO-203, 75 μg ALTO-203, and placebo as measured by the alertness and mood components of the Bond-Lader Visual Analog Scale (BL-VAS). | Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3 | 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. |
| Multi-Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the multi-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo. | Multi-Dose Treatment Period Day 1 to Day 35 | Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single Dose Period: To assess the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] during the single-dose treatment period for ALTO-203 25 μg and ALTO-203 75 μg as compared to placebo. | Single-Dose Treatment Period Day 1 to Day 21 | Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs. |
| Multi-Dose Period: To understand the pharmacokinetics (PK) of multi-doses of ALTO-203 in capsule formulation | Multi-Dose Treatment Period Day 1 to Day 35 | Bioanalysis of plasma samples and observed plasma concentrations of ALTO-203 after multiple days of dosing. |
Countries
United States
Outcome results
None listed