Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
NCT ID: NCT06633016
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
230 participants
INTERVENTIONAL
2024-09-20
2026-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 + 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Autobahn Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Autobahn Site #131
Birmingham, Alabama, United States
Autobahn Site #132
Chandler, Arizona, United States
Autobahn Site #116
Phoenix, Arizona, United States
Autobahn Site #136
Tucson, Arizona, United States
Autobahn Site #150
Anaheim, California, United States
Autobahn Site #113
Encino, California, United States
Autobahn Site #133
Encino, California, United States
Autobahn Site #124
Glendale, California, United States
Autobahn Site #140
Long Beach, California, United States
Autobahn Site #121
Los Alamitos, California, United States
Autobahn Site #117
Newport Beach, California, United States
Autobahn Site #106
Oceanside, California, United States
Autobahn Site #152
Orange, California, United States
Autobahn Site #151
Rancho Cucamonga, California, United States
Autobahn Site #119
San Jose, California, United States
Autobahn Site #126
Walnut Creek, California, United States
Autobahn Site #149
West Covina, California, United States
Autobahn Site #122
Cromwell, Connecticut, United States
Autobahn Site #108
Brandon, Florida, United States
Autobahn Site #110
Hialeah, Florida, United States
Autobahn Site #101
Jacksonville, Florida, United States
Autobahn Site #139
Lake City, Florida, United States
Autobahn Site #111
Miami, Florida, United States
Autobahn Site #141
Miami, Florida, United States
Autobahn Site #147
Miami Gardens, Florida, United States
Autobahn Site #102
Orlando, Florida, United States
Autobahn Site #148
Tampa, Florida, United States
Autobahn Site #123
Atlanta, Georgia, United States
Autobahn Site #112
Decatur, Georgia, United States
Autobahn Site #142
Peachtree Corners, Georgia, United States
Autobahn Site #120
Savannah, Georgia, United States
Autobahn Site #154
Elgin, Illinois, United States
Autobahn Site #137
Boston, Massachusetts, United States
Autobahn Site #138
Watertown, Massachusetts, United States
Autobahn Site #127
Saint Charles, Missouri, United States
Autobahn Site #130
Las Vegas, Nevada, United States
Autobahn Site #129
Berlin, New Jersey, United States
Autobahn Site #105
Brooklyn, New York, United States
Autobahn Site #134
Brooklyn, New York, United States
Autobahn Site #125
New York, New York, United States
Autobahn Site #104
Staten Island, New York, United States
Autobahn Site #109
Beachwood, Ohio, United States
Autobahn Site #107
Oklahoma City, Oklahoma, United States
Autobahn Site #128
North Charleston, South Carolina, United States
Autobahn Site #153
Beaumont, Texas, United States
Autobahn Site #146
San Antonio, Texas, United States
Autobahn Site #144
Sherman, Texas, United States
Autobahn Site #159
Orem, Utah, United States
Autobahn Site #145
Fairfax, Virginia, United States
Autobahn Site #143
Bellevue, Washington, United States
Countries
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Central Contacts
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Other Identifiers
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ABX-002-2001
Identifier Type: -
Identifier Source: org_study_id
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