Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)

NCT06633016 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, 2-arm, parallel-group, Phase 2 study, randomized 1:1 (ABX-002: placebo). The study will include the following stages: 1. Screening, approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period 4. 6-month postdose targeted safety follow-up period

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG ABX-002

Study Locations (20)

California

  • Autobahn Site #150 — Anaheim
  • Autobahn Site #113 — Encino
  • Autobahn Site #133 — Encino
  • Autobahn Site #124 — Glendale
  • Autobahn Site #140 — Long Beach
  • Autobahn Site #121 — Los Alamitos
  • Autobahn Site #117 — Newport Beach
  • Autobahn Site #106 — Oceanside
  • Autobahn Site #152 — Orange
  • Autobahn Site #151 — Rancho Cucamonga
  • Autobahn Site #119 — San Jose
  • Autobahn Site #126 — Walnut Creek
  • Autobahn Site #149 — West Covina

Arizona

  • Autobahn Site #132 — Chandler
  • Autobahn Site #116 — Phoenix
  • Autobahn Site #136 — Tucson

Florida

  • Autobahn Site #108 — Brandon
  • Autobahn Site #110 — Hialeah

Alabama

  • Autobahn Site #131 — Birmingham

Connecticut

  • Autobahn Site #122 — Cromwell

Trial Details

FieldValue
Enrollment Target 230 participants
Start Date 2024-09-20
Est. Completion 2026-06
Phase Phase 2

Sponsor

Autobahn Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06633016

The ClinicalTrials.gov registry entry for NCT06633016 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Autobahn Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06633016 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06633016 about?

NCT06633016 is a clinical study titled "Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)". The goal of this clinical trial is to learn if ABX-002 added to an existing antidepressant treatment will benefit depression symptoms in adults with moderate to severe major depressive disorder who have had an inadequate response to their antidepressant. This is a double-blind, placebo-controlled, ...

What is the current status of trial NCT06633016?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2024-09-20. Estimated completion is 2026-06.

What conditions does trial NCT06633016 study?

This clinical trial studies the following conditions: Major Depressive Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06633016?

The interventions under investigation include: Placebo (OTHER), ABX-002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06633016?

This trial is sponsored by Autobahn Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06633016 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial