A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder
Overview
- Phase
- Phase 2
- Intervention
- ABX-002
- Conditions
- Major Depressive Disorder
- Sponsor
- Autobahn Therapeutics, Inc.
- Enrollment
- 230
- Locations
- 48
- Primary Endpoint
- Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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:
- Screening, approximately 35 days
- 42-day Treatment Period
- 2-week post dose Safety Follow-up Period
- 6-month postdose targeted safety follow-up period
Investigators
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 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, 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
Arms & Interventions
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.
Intervention: ABX-002
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Change from Baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Time Frame: 6 weeks
The HAMD-17 is a clinician-based assessment of depressive symptoms. Higher scores indicate worse symptoms. A score of 0-9 is generally accepted to be within the normal range (or in clinical remission), while a score of greater than 17 indicates moderate to severe depression symptoms.
Secondary Outcomes
- Change from Baseline for Clinical Global Impression of Severity (CGI-S)(6 weeks)
- Change from Baseline for Sheehan Disability Scale (SDS)(6 weeks)
- Change from baseline for 6-item Hamilton Rating Scale for Depression (HAMD-6)(6 weeks)
- Change from baseline for 29-item Hamilton Rating Scale for Depression (HAMD-29)(6 weeks)
- Patient Global Impression-Improvement (PGI-I)(6 weeks)
- Assessment of safety and tolerability of ABX-002 compared with placebo using adverse events(6 weeks)