Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
Purpose
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, Eligibility evaluation and 1:1 Randomization to ABX-002 vs. Placebo control (Baseline - Day 1); approximately 35 days 2. 42-day Treatment Period 3. 2-week post dose Safety Follow-up Period
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Meets the DSM-5 criteria for Major Depressive Disorder, with a current major depressive episode duration being no longer than 12 months. - A score of ≤ 22 (midrange mild/moderate) on the Hamilton Anxiety Rating Scale. - Montgomery-Asberg Depression Rating Scale total score [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 but not more than 12 months 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. - History 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. History 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, cardiovascular, gastrointestinal, respiratory, renal, hepatic, immunological, hematological, endocrine, 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 - 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 within 90 days of the last dose of study drug, 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 - 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 7 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- The study participants, Investigator, and study site staff, Sponsor will be blinded to treatment assignments (ABX-002 or placebo solution).
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Autobahn Therapeutics, Inc.
