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NCT06633016 · ClinicalTrials.gov registry record · Phase 2
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
A Phase 2 study of Major Depressive Disorder, sponsored by Autobahn Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT06633016: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Autobahn Therapeutics.
NCT06633016 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Autobahn Therapeutics. The registered enrollment target is 230 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06633016, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Autobahn Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
The HAMD-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
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
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT06633016 shows while recruiting
NCT06633016 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (39% lower).
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.
NCT06633016 names 20 study sites across 5 states, led by California, Arizona, Florida.
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.
What interventions are being tested in trial NCT06633016?
The interventions under investigation include: Placebo (OTHER), ABX-002 (DRUG).
Who is sponsoring clinical trial NCT06633016?
This trial is sponsored by Autobahn Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06633016's enrollment target sits among peer trials
230 66th of 282 higher than 217 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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