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New depression drug candidate ABX-002 enters Mid-Stage trial

NCT ID NCT06633016

Symptom relief Sponsor: Autobahn Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding ABX-002 to a current antidepressant can improve symptoms in adults with moderate to severe major depression. About 230 participants will receive either ABX-002 or a placebo for 6 weeks, with follow-up for up to 6 months. The goal is to see if ABX-002 reduces depression scores more than placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABX-002 (oral solution)
What this could lead to
If successful, ABX-002 could offer a new option for people with depression who don't get enough relief from standard antidepressants.
What could go wrong
This is an early Phase 2 study with only 230 participants, so results may not apply to everyone. The drug may prove no better than placebo or cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets the DSM-5 criteria for Major Depressive Disorder, with a current major depressive episode duration of \> 6 weeks and ≤ 18 months. * A score of ≤ 22 (midrange mild/moderate) on the Hamilton Anxiety Rating Scale. * Montgomery-Asberg Depression Rating Scale total score of \> 24 \[indicating moderate to severe depression\] at Screening and at Baseline. * Subject is compliantly using a single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant for at least 6 weeks for their current episode of depression, with an adequate dose, and with an inadequate response as defined by the Antidepressant Treatment Response Questionnaire. The dosage of the current antidepressant must have been stable for the past 4 weeks, and the dosage and specific antidepressant used should remain the same from Screening through the end of the Follow-up Period. Exclusion Criteria: Note: History implies lifetime history, unless otherwise specified * History of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features or concomitant DSM-5 depressive disorders, bipolar I or II disorder, cyclothymic disorder, delirium, dementia, amnestic disorder, or cognitive disorder. * Current diagnosis or active symptoms within the last 2 years of obsessive-compulsive disorder, posttraumatic stress disorder, panic disorder, or eating disorder, according to DSM-5 criteria. * Primary diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder, according to DSM-5 criteria. Current or history within the last 2 years of self-injurious behavior is exclusionary. * Has failed more than 2 single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant treatments, including the current serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor, during the current depressive episode, despite an adequate dose (per Antidepressant Treatment Response Questionnaire) and duration (at least 6 weeks). * Failure to respond to triiodothyronine or thyroxine augmentation for the treatment of depression. * Started new psychotherapy or had a change in the intensity of psychotherapy within 8 weeks before Screening. * Is suicidal at Screening or Baseline * History or current evidence within previous 3 months before Screening of uncontrolled, clinically significant neurological, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, or other medical disorder, including cancer, that would jeopardize the safe participation of the subject in the study (in the opinion of the Investigator). * History of thyroid disease * History of multiple endocrine neoplasia syndrome * Diagnosis of epilepsy or history of convulsions, including childhood febrile seizure. Use of co-administered drugs that may lower seizure threshold is excluded. * Females who are pregnant, intend to become pregnant or are breastfeeding. * Antidepressants: Prior use of psychedelics, ketamine, or esketamine, for the treatment of Major Depressive Disorder. * Antidepressants: Current use, or use within 4 weeks prior to Screening, of any other augmentation agents for Major Depressive Disorder (e.g. second-generation antipsychotics \[SGA\], monoamine oxidase inhibitors \[MAOI\], tricyclic antidepressants \[TCA\], lithium, or bupropion) * Current or prior use of treatment for hypothyroidism including but not limited to synthetic or natural thyroid hormone, triiodothyronine and/or thyroxine. * Concomitant use of biotin of any dose and in any preparation 14 days prior to Day 1 until after the last study visit at Week 8 (Day 56). * Medications that are strong cytochrome P450 3A4 inhibitors or strong cytochrome P450 3A4 inducers are not allowed. * Prescription drug/controlled substance abuse, or illicit substance use within 1 year of Screening or positive urine drug results at Screening or Baseline for an illicit substance. * History or presence of cataract on ophthalmic examination (including slit-lamp), glaucoma, inflammatory eye disease or prior ophthalmic surgical procedures or laser surgery in either eye

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    32 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Autobahn Site #101

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Autobahn Site #102

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32822, United States

  • Autobahn Site #104

    RECRUITING

    Staten Island, New York, 10314, United States

  • Autobahn Site #105

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Autobahn Site #106

    ACTIVE_NOT_RECRUITING

    Oceanside, California, 92056, United States

  • Autobahn Site #107

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Autobahn Site #108

    RECRUITING

    Brandon, Florida, 33511, United States

  • Autobahn Site #109

    RECRUITING

    Beachwood, Ohio, 44122, United States

  • Autobahn Site #110

    RECRUITING

    Hialeah, Florida, 33012, United States

  • Autobahn Site #111

    RECRUITING

    Miami, Florida, 33144, United States

  • Autobahn Site #112

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Autobahn Site #113

    WITHDRAWN

    Encino, California, 91316, United States

  • Autobahn Site #116

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85102, United States

  • Autobahn Site #117

    WITHDRAWN

    Newport Beach, California, 92660, United States

  • Autobahn Site #119

    RECRUITING

    San Jose, California, 95124, United States

  • Autobahn Site #120

    ACTIVE_NOT_RECRUITING

    Savannah, Georgia, 31405, United States

  • Autobahn Site #121

    WITHDRAWN

    Los Alamitos, California, 90720, United States

  • Autobahn Site #122

    RECRUITING

    Cromwell, Connecticut, 06416, United States

  • Autobahn Site #123

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30328, United States

  • Autobahn Site #124

    RECRUITING

    Glendale, California, 91206, United States

  • Autobahn Site #125

    ACTIVE_NOT_RECRUITING

    New York, New York, 10022, United States

  • Autobahn Site #126

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Autobahn Site #127

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Autobahn Site #128

    ACTIVE_NOT_RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Autobahn Site #129

    RECRUITING

    Berlin, New Jersey, 08009, United States

  • Autobahn Site #130

    WITHDRAWN

    Las Vegas, Nevada, 89121, United States

  • Autobahn Site #131

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • Autobahn Site #132

    ACTIVE_NOT_RECRUITING

    Chandler, Arizona, 85224, United States

  • Autobahn Site #133

    WITHDRAWN

    Encino, California, 91316, United States

  • Autobahn Site #134

    RECRUITING

    Brooklyn, New York, 11235, United States

  • Autobahn Site #136

    WITHDRAWN

    Tucson, Arizona, 85704, United States

  • Autobahn Site #137

    RECRUITING

    Boston, Massachusetts, 02130, United States

  • Autobahn Site #138

    ACTIVE_NOT_RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Autobahn Site #139

    ACTIVE_NOT_RECRUITING

    Lake City, Florida, 32055, United States

  • Autobahn Site #140

    RECRUITING

    Long Beach, California, 90807, United States

  • Autobahn Site #141

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33157, United States

  • Autobahn Site #142

    RECRUITING

    Peachtree Corners, Georgia, 30071, United States

  • Autobahn Site #143

    RECRUITING

    Bellevue, Washington, 98007, United States

  • Autobahn Site #144

    RECRUITING

    Sherman, Texas, 75092, United States

  • Autobahn Site #145

    RECRUITING

    Fairfax, Virginia, 22030, United States

  • Autobahn Site #146

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Autobahn Site #147

    RECRUITING

    Miami Gardens, Florida, 33014, United States

  • Autobahn Site #148

    RECRUITING

    Tampa, Florida, 33629, United States

  • Autobahn Site #149

    RECRUITING

    West Covina, California, 91790, United States

  • Autobahn Site #150

    RECRUITING

    Anaheim, California, 92805, United States

  • Autobahn Site #151

    RECRUITING

    Rancho Cucamonga, California, 91730, United States

  • Autobahn Site #152

    RECRUITING

    Orange, California, 92866, United States

  • Autobahn Site #153

    RECRUITING

    Beaumont, Texas, 77701, United States

  • Autobahn Site #154

    ACTIVE_NOT_RECRUITING

    Elgin, Illinois, 60123, United States

  • Autobahn Site #159

    RECRUITING

    Orem, Utah, 84058, United States

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Other studies related to the condition(s) this trial covers.