Major Depressive DisorderPhase 2NCT06633016
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
A Phase 2 study testing ABX-002 in people with Major Depressive Disorder, run by Autobahn Therapeutics, Inc. at 50 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ABX-002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 50 sitesUnited States
- Study dates
- 20 Sep 2024to Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
50 sites in 1 country. Contact the study team or a site near you to ask about taking part.
50 sites in 1 country
United States50 sites, 32 recruiting
- Recruiting
Autobahn Site #150
Anaheim, California, 92805
- Active, not recruiting
Autobahn Site #123
Atlanta, Georgia, 30328
- Recruiting
Autobahn Site #109
Beachwood, Ohio, 44122
- Recruiting
Autobahn Site #153
Beaumont, Texas, 77701
- Recruiting
Autobahn Site #143
Bellevue, Washington, 98007
- Recruiting
Autobahn Site #129
Berlin, New Jersey, 08009
- Recruiting
Autobahn Site #131
Birmingham, Alabama, 35294
- Recruiting
Autobahn Site #137
Boston, Massachusetts, 02130
- Recruiting
Autobahn Site #108
Brandon, Florida, 33511
- Recruiting
Autobahn Site #105
Brooklyn, New York, 11229
- Recruiting
Autobahn Site #134
Brooklyn, New York, 11235
- Active, not recruiting
Autobahn Site #132
Chandler, Arizona, 85224
- Recruiting
Autobahn Site #122
Cromwell, Connecticut, 06416
- Recruiting
Autobahn Site #112
Decatur, Georgia, 30030
- Active, not recruiting
Autobahn Site #154
Elgin, Illinois, 60123
- Withdrawn
Autobahn Site #113
Encino, California, 91316
- Withdrawn
Autobahn Site #133
Encino, California, 91316
- Recruiting
Autobahn Site #145
Fairfax, Virginia, 22030
- Recruiting
Autobahn Site #124
Glendale, California, 91206
- Recruiting
Autobahn Site #110
Hialeah, Florida, 33012
- Recruiting
Autobahn Site #101
Jacksonville, Florida, 32256
- Active, not recruiting
Autobahn Site #139
Lake City, Florida, 32055
- Withdrawn
Autobahn Site #130
Las Vegas, Nevada, 89121
- Recruiting
Autobahn Site #140
Long Beach, California, 90807
- Withdrawn
Autobahn Site #121
Los Alamitos, California, 90720
- Recruiting
Autobahn Site #111
Miami, Florida, 33144
- Active, not recruiting
Autobahn Site #141
Miami, Florida, 33157
- Recruiting
Autobahn Site #147
Miami Gardens, Florida, 33014
- Active, not recruiting
Autobahn Site #125
New York, New York, 10022
- Withdrawn
Autobahn Site #117
Newport Beach, California, 92660
- Active, not recruiting
Autobahn Site #128
North Charleston, South Carolina, 29405
- Active, not recruiting
Autobahn Site #106
Oceanside, California, 92056
- Recruiting
Autobahn Site #107
Oklahoma City, Oklahoma, 73112
- Recruiting
Autobahn Site #152
Orange, California, 92866
- Recruiting
Autobahn Site #159
Orem, Utah, 84058
- Active, not recruiting
Autobahn Site #102
Orlando, Florida, 32822
- Recruiting
Autobahn Site #142
Peachtree Corners, Georgia, 30071
- Active, not recruiting
Autobahn Site #116
Phoenix, Arizona, 85102
- Recruiting
Autobahn Site #151
Rancho Cucamonga, California, 91730
- Recruiting
Autobahn Site #127
Saint Charles, Missouri, 63304
- Recruiting
Autobahn Site #146
San Antonio, Texas, 78215
- Recruiting
Autobahn Site #119
San Jose, California, 95124
- Active, not recruiting
Autobahn Site #120
Savannah, Georgia, 31405
- Recruiting
Autobahn Site #144
Sherman, Texas, 75092
- Recruiting
Autobahn Site #104
Staten Island, New York, 10314
- Recruiting
Autobahn Site #148
Tampa, Florida, 33629
- Withdrawn
Autobahn Site #136
Tucson, Arizona, 85704
- Recruiting
Autobahn Site #126
Walnut Creek, California, 94596
- Active, not recruiting
Autobahn Site #138
Watertown, Massachusetts, 02472
- Recruiting
Autobahn Site #149
West Covina, California, 91790
About this study
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder
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:
- Screening, approximately 35 days
- 42-day Treatment Period
- 2-week post dose Safety Follow-up Period
- 6-month postdose targeted safety follow-up period
- Conditions
- Major Depressive Disorder
- Being tested
- ABX-002, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABX-002Drug
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ABX-002 + SSRI/SNRI | Experimental | 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. Receives: Drug: ABX-002 |
| Placebo + SSRI/SNRI | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
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.
Measured: 6 weeks
Secondary outcomes (6)
Change from Baseline for Clinical Global Impression of Severity (CGI-S)
a 7-point rating scale used to measure illness and symptom severity in subjects with mental disorders. The greater the number the more severe.
Measured: 6 weeks
Change from Baseline for Sheehan Disability Scale (SDS)
Self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in the occupational, social, and family domains.
Measured: 6 weeks
Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)
Six-item scale used to assess the core symptoms of depression.
Measured: 6 weeks
Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)
Clinician-based assessment of depressive symptoms. HAMD-29 covers HAMD-6, HAMD-17 (items 1 to 17), the Melancholia Scale (MES) (items 18 to 23), and the neurovegetative symptoms (NVS) (items 24 to 28).
Measured: 6 weeks
Patient Global Impression-Improvement (PGI-I)
Quality-of-life questionnaire to assess improvement of activities of daily living, wellbeing, and function.
Measured: 6 weeks
Assessment of safety and tolerability of ABX-002 compared with placebo using adverse events
Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start20 Sep 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Autobahn Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633016
- Sponsor's protocol ID
- ABX-002-2001
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06633016
- Acronym / sponsor ID
- ABX-002-2001
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Autobahn Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening, approximately 35 days
- 42-day Treatment Period
- 2-week post dose Safety Follow-up Period
- 6-month postdose targeted safety follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABX-002 + SSRI/SNRI | Experimental | Drug: ABX-002Patients 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 + SSRI/SNRI | Placebo comparator | Other: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABX-002ABX-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. | Drug | ABX-002 + SSRI/SNRI |
| PlaceboComparator 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. | Other | Placebo + SSRI/SNRI |
Primary outcome
Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Time frame: 6 weeks
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.
6 secondary outcomes
Change from Baseline for Clinical Global Impression of Severity (CGI-S)
Time frame: 6 weeks
Change from Baseline for Sheehan Disability Scale (SDS)
Time frame: 6 weeks
Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)
Time frame: 6 weeks
Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)
Time frame: 6 weeks
Patient Global Impression-Improvement (PGI-I)
Time frame: 6 weeks
Assessment of safety and tolerability of ABX-002 compared with placebo using adverse events
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABX-002 in people with Major Depressive Disorder, run by Autobahn Therapeutics, Inc. at 50 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashlee Heldreth, MS (8582573418, clinicaltrials@autobahntx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.