Phase 2
Completed N=104
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
Source: ClinicalTrials.gov NCT03193398 ↗Enrolled (actual)
104
Serious AEs
1.0%
Results posted
May 2021
Primary outcomePrimary: Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo — -15.0; -13.6 Change in score on a scale from baseline — p=0.5939
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo |
-15.0; -13.6 | 0.5939 |
| SECONDARY Change From Baseline in Investigator-administered MADRS-6 Total Score |
-10.7; -9.7 | 0.5503 |
| SECONDARY Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score |
-2.6; -3.5 | 0.3906 |
| SECONDARY Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score |
-5.0; -5.9 | 0.4187 |
| SECONDARY Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) |
13.7; 2.91 | 0.4869 |
| SECONDARY Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score |
-6.7; -7.9 | 0.5178 |
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.
Data sourced from ClinicalTrials.gov (NCT03193398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.