ALTO-207 in Adults With Treatment-resistant Depression (TRD)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Alto Neuroscience
Study ID
NCT07553637
Phase
PHASE2
Status
Recruiting

Conditions

  • Treatment-resistant Depression (TRD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ALTO-207 — DRUG
    ALTO-207 BID
  • Placebo — DRUG
    Matching Placebo

Study Details

The purpose of this trial is to measure depressive symptoms following treatment with ALTO-207 compared with placebo in participants with TRD.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ALTO-207
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in the MADRS total score [ Time Frame: Change from baseline up to 8 weeks ]

Central Contacts

Locations (38)

FacilityCityStateZIPSite coordinators
Site 7074BirminghamAlabama35294-
Site 7173DothanAlabama36345-
Site 7000PhoenixArizona85012-
Site 7153ChinoCalifornia91710-
Site 7156OaklandCalifornia94610-
Site 7082OceansideCalifornia92056-
Site 7159Palo AltoCalifornia94304-
Site 7016SacramentoCalifornia95655-
Site 7144San DiegoCalifornia92123-
Site 7171Valley VillageCalifornia91607-
Site 7152Saint AugustineFlorida32086-
Site 7148AlbanyGeorgia31707-
Site 7146AtlantaGeorgia30060-
Site 7064Peachtree CornersGeorgia30078-
Site 7141SavannahGeorgia31406-
Site 7169IndianapolisIndiana46202-
Site 7151AnnapolisMaryland21401-
Site 7054PikesvilleMaryland21208-
Site 7166WorcesterMassachusetts01606-
Site 7155Ann ArborMichigan48109-
Site 7154Bloomfield HillsMichigan48302-
Site 7170AmherstNew York14226-
Site 7055CedarhurstNew York11516-
Site 7162LewistonNew York14214-
Site 7157SyracuseNew York13210-
Site 7143CharlotteNorth Carolina28287-
Site 7029CincinnatiOhio45215-
Site 7158Garfield HeightsOhio44125-
Site 7172East ProvidenceRhode Island02914-
Site 7176DallasTexas75243-
Site 7160Fort WorthTexas76104-
Site 7150GalvestonTexas77555-
Site 7145HoustonTexas77030-
Site 7175HoustonTexas77007-
Site 7161IrvingTexas75062-
Site 7177FairfaxVirginia22030-
Site 7128SeattleWashington98004-
Site 7163South CharlestonWest Virginia25303-

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