A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy And Safety Study Of BTRX-246040 Administered Once Daily In Patients With Major Depressive Disorder With Or Without Anhedonia
Overview
- Phase
- Phase 2
- Intervention
- BTRX-246040 oral capsule(s)
- Conditions
- Major Depressive Disorder
- Sponsor
- BlackThorn Therapeutics, Inc.
- Enrollment
- 104
- Locations
- 2
- Primary Endpoint
- Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will determine the efficacy, safety, and tolerability of a once-daily (QD) dose of up to 80 mg of BTRX-246040 for 8 weeks in participants with MDD.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with a diagnosis of MDD as defined by DSM-5 criteria and have had at least 1 prior major depressive episode in the past 10 years
- •Patients must present with a new current episode of MDD and the duration of the current episode must be at least 4 weeks but not longer than 18 months.
- •At Visit 1 (screening) and Visit 2 (baseline), patients must have clinically significant depressive symptoms defined by tandem (investigator- and computer-administered) Montgomery-Asberg Depression Rating Scale (MADRS) total scores ≥ 26 with a difference of ≤ 7 points between the Investigator- and computer-administered MADRS total scores
- •Patients must have a CGI-S score ≥ 4 at Visit 2 (baseline).
Exclusion Criteria
- •Patients who present with any current DSM-5 disorder other than MDD which is the focus of treatment.
- •Patients who are homicidal in the opinion of the Investigator or are at suicidal risk (any suicide attempts within 12 months prior to Visit 1 \[screening\] or any suicidal intent, including a plan, within 3 months prior to Visit 1 \[screening\]; C-SSRS answer of "YES" on item 4 or 5 \[suicidal ideation\]; Investigator- or computer-administered MADRS score of ≥ 5 on item 10 \[suicidal thoughts\]; by Investigator clinical evaluation).
- •Patients cannot have any history of substance or alcohol use disorder within 12 months prior to Visit 1 (screening) per DSM-5 criteria
- •Patients must not have a clinically significant comorbid disease.
Arms & Interventions
BTRX-246040
40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.
Intervention: BTRX-246040 oral capsule(s)
Placebo
administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.
Intervention: Placebo oral capsule(s)
Outcomes
Primary Outcomes
Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo
Time Frame: Week 8
The Investigator-administered MADRS includes 10 items assessing the following symptoms: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 60. MADRS total scores from 0 to 6 indicate normal/symptom absent, from 7 to 19 indicate mild depression, from 20 to 34 indicate moderate depression, and from 35 to 60 indicate severe depression.
Secondary Outcomes
- Change From Baseline in Investigator-administered MADRS-6 Total Score(Week 8)
- Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score(Week 8)
- Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score(Week 8)
- Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)(Week 8)
- Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score(Week 8)