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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 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.

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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

Conditions Studied

Major Depressive Disorder

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

3 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, categorized as Phase 2. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (39% lower). The listed sponsor is Autobahn Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.