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New treatment option for Major Depressive Disorder
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?
ABX-002 is an investigational medicine, given as a pill taken by mouth, being studied as a potential 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 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).
- 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. Current or history within the last 2 years of self-injurious behavior is...
- 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. second-generation antipsychotics [SGA], monoamine oxidase inhibitors [MAOI]...
- 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's taking place
- Birmingham, Alabama, United States
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Anaheim, California, United States
- Encino, California, United States
- Glendale, California, United States
- Long Beach, California, United States
- Los Alamitos, California, United States
- Newport Beach, California, United States
- Oceanside, 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
+ 27 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 - 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?
Study sites include Birmingham, Alabama, United States; Chandler, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Anaheim, California, United States; Encino, California, United States and 41 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.