Recruiting
Phase 2

ABX-002

Sponsor:

Autobahn Therapeutics, Inc.

Code:

NCT06633016

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ABX-002

Placebo

Study Details

Brief 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

Major Depressive Disorder

Study ID

NCT06633016

Start date

Sep 20, 2024

Status verified date

Jan, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABX-002 + SSRI/SNRI

Patients continue to receive their selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study in addition to ABX-002.

placebo comparator: Placebo + SSRI/SNRI

Patients continue to receive their selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study in addition to the Placebo.

Interventions

ABX-002

ABX-002 oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

Placebo

Comparator Placebo oral solution in 1-mL cyclic olefin polymer prefilled syringes, taken on an empty stomach first thing in the morning followed by 240 mL (8 oz) of water.

Primary outcome measure

  • Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Ashlee Heldreth, MS

8582573418clinicaltrials@autobahntx.com

Locations

Autobahn Site #131

Recruiting

Birmingham, Alabama, United States, 35294

Autobahn Site #150

Recruiting

Anaheim, California, United States, 92805

Autobahn Site #124

Recruiting

Glendale, California, United States, 91206

Autobahn Site #140

Recruiting

Long Beach, California, United States, 90807

Autobahn Site #152

Recruiting

Orange, California, United States, 92866

Autobahn Site #151

Recruiting

Rancho Cucamonga, California, United States, 91730

Autobahn Site #119

Recruiting

San Jose, California, United States, 95124

Autobahn Site #126

Recruiting

Walnut Creek, California, United States, 94596

Autobahn Site #149

Recruiting

West Covina, California, United States, 91790

Autobahn Site #122

Recruiting

Cromwell, Connecticut, United States, 06416

Autobahn Site #108

Recruiting

Brandon, Florida, United States, 33511

Autobahn Site #110

Recruiting

Hialeah, Florida, United States, 33012

Autobahn Site #101

Recruiting

Jacksonville, Florida, United States, 32256

Autobahn Site #111

Recruiting

Miami, Florida, United States, 33144

Autobahn Site #147

Recruiting

Miami Gardens, Florida, United States, 33014

Autobahn Site #148

Recruiting

Tampa, Florida, United States, 33629

Autobahn Site #112

Recruiting

Decatur, Georgia, United States, 30030

Autobahn Site #142

Recruiting

Peachtree Corners, Georgia, United States, 30071

Autobahn Site #137

Recruiting

Boston, Massachusetts, United States, 02130

Autobahn Site #127

Recruiting

Saint Charles, Missouri, United States, 63304

Autobahn Site #129

Recruiting

Berlin, New Jersey, United States, 08009

Autobahn Site #105

Recruiting

Brooklyn, New York, United States, 11229

Autobahn Site #134

Recruiting

Brooklyn, New York, United States, 11235

Autobahn Site #104

Recruiting

Staten Island, New York, United States, 10314

Autobahn Site #109

Recruiting

Beachwood, Ohio, United States, 44122

Autobahn Site #107

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Autobahn Site #153

Recruiting

Beaumont, Texas, United States, 77701

Autobahn Site #146

Recruiting

San Antonio, Texas, United States, 78215

Autobahn Site #144

Recruiting

Sherman, Texas, United States, 75092

Autobahn Site #159

Recruiting

Orem, Utah, United States, 84058

Autobahn Site #145

Recruiting

Fairfax, Virginia, United States, 22030

Autobahn Site #143

Recruiting

Bellevue, Washington, United States, 98007

More Information

Sponsor

Autobahn Therapeutics, Inc.

Last update posted

Jan 20, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Autobahn Therapeutics, Inc. on 2026-01-20.