CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 104 enrolled
Drug / intervention
BTRX-246040 oral capsule(s) +1 moredrug
Likely dose
BTRX-246040 administered once dailyAI-extracted
Key inclusion· 4
  • ✓Diagnosed with Major Depressive Disorder per DSM-5 criteria with at least 1 prior major depressive episode in the past 10 years
  • ✓Current MDD episode duration between 4 weeks and 18 months
  • ✓MADRS total score ≥26 at screening and baseline (investigator- and computer-administered, difference ≤7 points)
  • ✓CGI-S score ≥4 at baseline
Key exclusion· 4
  • ✕Any current DSM-5 psychiatric disorder other than MDD
  • ✕Active suicidality: any suicide attempts within 12 months prior to screening, or suicidal intent/plan within 3 months prior to screening, or C-SSRS 'YES' on items 4-5, or MADRS item 10 ≥5, or investigator clinical evaluation
  • ✕History of substance or alcohol use disorder within 12 months prior to screening (DSM-5 criteria)
  • ✕Clinically significant comorbid disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193398
NCT03193398Phase 2Completed
CompareCT.gov

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

BlackThorn Therapeutics, Inc.·interventional·Posted Jun 20, 2017·Updated May 11, 2021

In Brief

A Phase 2 clinical trial evaluating BTRX-246040 oral capsule(s) and Placebo oral capsule(s) for Major Depressive Disorder. Completed, enrolled 104 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 20, 2017
Enrollment StartJun 12, 2017
Primary CompletionNov 12, 2018
Study CompletionDec 12, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.0 years ago

Interventions

BTRX-246040 oral capsule(s)drug

BTRX-246040 administered once daily to patients with MDD for 8 weeks

Placebo oral capsule(s)drug

administered once daily to patients with MDD for 8 weeks