Major Depressive Disorder study: ABX-002
Official title Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
ClinicalTrials.gov ID: NCT06633016
What this study is testing
What is ABX-002?
an investigational oral solution being studied as a potential add‑on treatment for major depressive disorder
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding ABX-002 to an existing antidepressant can improve depression symptoms in adults whose current medication isn’t working well enough.
- Who it's for
- Adults with moderate to severe major depressive disorder who have had an inadequate response to their current antidepressant.
- What's involved
- Participants will continue their current antidepressant and be randomly given either ABX-002 or a placebo for 42 days. The trial includes screening, treatment visits, and safety check‑ups.
- Time commitment
- The study lasts about 9 months total: ~35‑day screening, 42‑day treatment, a 2‑week safety follow‑up, and a 6‑month safety follow‑up, with several clinic visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
You likely can't join if
- 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...
- Current diagnosis or active symptoms within the last 2 years of obsessive-compulsive disorder, posttraumatic stress disorder, panic disorder, or...
- Primary diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder, according to DSM-5 criteria.
- Has failed more than 2 single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant treatments...
- Failure to respond to triiodothyronine or thyroxine augmentation for the treatment of depression.
See the full eligibility 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...
- 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...
- 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.
- Has failed more than 2 single selective serotonin reuptake inhibitors / serotonin norepinephrine reuptake inhibitor antidepressant treatments, including the current serotonin reuptake inhibitors / serotonin...
- 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Anaheim, California, United States
- Glendale, California, United States
- Long Beach, California, United States
- Orange, California, United States
- Rancho Cucamonga, California, United States
- San Jose, California, United States
- Walnut Creek, California, United States
- West Covina, California, United States
- Cromwell, Connecticut, United States
- Brandon, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Tampa, Florida, United States
- Decatur, Georgia, United States
- Peachtree Corners, Georgia, United States
- Boston, Massachusetts, United States
- Saint Charles, Missouri, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Anaheim, California, United States; Glendale, California, United States; Long Beach, California, United States; Orange, California, United States; Rancho Cucamonga, California, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.