NCT06391593Phase 2Completed

PD, PK, and Safety of ALTO-203 in Patients With MDD

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2025-04-14Actual

Enrollment · participants69Actual

Source updated2026-04-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-10-20 · 5 fields changed

Participant count type changed

− Before

~~Estimated~~

+ After

Actual

Enrollment · participant count changed

− Before

~~60 participants (planned)~~

+ After

69 participants (actual)

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~Apr 2025~~

+ After

14 Apr 2025

Recruitment status changed

− Before

~~Recruiting~~

+ After

Completed

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Study details

Conditions studied

Major Depressive Disorder; Anhedonia

Treatments or interventions studied

ALTO-203 25 μgDrug
ALTO-203 75 μgDrug
PlaceboDrug

Primary outcomes · main study measures

Read the study measures

measure: 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).; description: 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.; timeFrame: Single-Dose Treatment Period - Pre-Dose, 1.5 hours, 3 hours, and 5 hours on Day 1 at Treatments 1, 2, and 3; measure: 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.; description: Incidence, severity, and relatedness of TEAEs, SAEs, discontinuation due to TEAEs.; timeFrame: Multi-Dose Treatment Period Day 1 to Day 35

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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