Recruiting NCT07553637
ALTO-207 in Adults With Treatment-resistant Depression (TRD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALTO-207, Placebo.
- Who it may be relevant to
- Registry conditions: Treatment-resistant Depression (TRD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-blind, Placebo-controlled Trial of ALTO-207 in Adults With Treatment-resistant Depression
Overview
The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.
Interventions
- Drug ALTO-207
ALTO-207 BID - Drug Placebo
Matching Placebo
Primary outcome measures
- Change in the MADRS total score [Time frame: Change from baseline up to 8 weeks]
Secondary outcome measures (2)
- Change in response (≥50% improvement) raters based on MADRS [Time frame: Change from baseline up to 8 weeks]
- Change in the Clinician-administered CGI-S score over time from Baseline to Week 8 [Time frame: Change from baseline up to 8 weeks]
Eligibility criteria
Inclusion criteria
- Male and female participants, ages 18 to 75 years, inclusive, at the time of signing the ICF.
- Prior diagnosis of MDD without psychotic symptoms (in the current episode) and have confirmatory diagnosis of current MDD (moderate to severe).
- Failure to respond (<50% improvement) to at least 2-5 antidepressant treatments (including the current treatment)
- Currently taking a stable dose of at least 1 but no more than 2 oral antidepressants at baseline
Exclusion criteria
- Evidence of unstable medical condition
- Concurrent use of any prohibited medications or substance use disorder
- Diagnosed bipolar disorder or a psychotic disorder or symptoms
- Significant current PTSD symptoms or history of PTSD
- Clinically significant current impulse control difficulties
- Has a history of hypersensitivity or allergic reaction to ALTO-207 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 38 centers
- Site 7074 — Birmingham
- Site 7173 — Dothan
- Site 7000 — Phoenix
- Site 7153 — Chino
- Site 7156 — Oakland
- Site 7082 — Oceanside
- Site 7159 — Palo Alto
- Site 7016 — Sacramento
- … and 30 more centers
United Kingdom · 10 centers
- Site 7419 — Antrim
- Site 7411 — Birmingham
- Site 7414 — Bristol
- Site 7412 — Cardiff
- Site 7418 — Exeter
- Site 7415 — London
- Site 7413 — Nottingham
- Site 7410 — Oxford
- … and 2 more centers
Identifiers
NCT: NCT07553637 · ALTO-207-201