Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
Trial Parameters
Brief 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. 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
Eligibility Criteria
Inclusion 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 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: Note: History implies lifetime history, unless otherwise specifi