BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2018-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Assess the Effects of Oral NMRA-335140 in Participants With Major Depressive Disorder

NCT06058039

Major Depressive Disorder

RECRUITING PHASE3

Study to Assess the Effects of Oral NMRA-335140 Versus Placebo in Participants With Major Depressive Disorder

NCT06058013

Major Depressive Disorder

RECRUITING PHASE3

Study of the Efficacy and Safety of LY2940094 in Participants With Major Depressive Disorder (MDD)

NCT01724112

Major Depressive Disorder

COMPLETED PHASE2

Trial to Determine the Maximum Tolerated Dose (MTD) Based on Safety and Tolerability, of Org 26576 in Participants With Major Depressive Disorder (174001/P05704/MK-8777-001)

NCT00610649

Depression

COMPLETED PHASE2

A Study to Explore the Efficacy of JNJ-89495120 in the Treatment of Major Depressive Disorder

NCT06785012

Depressive Disorder, Major

RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BTRX-246040

40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks.

Group Type EXPERIMENTAL

BTRX-246040 oral capsule(s)

Intervention Type DRUG

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

Placebo

administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks.

Group Type PLACEBO_COMPARATOR

Placebo oral capsule(s)

Intervention Type DRUG

administered once daily to patients with MDD for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BTRX-246040 oral capsule(s)

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

Intervention Type DRUG

Placebo oral capsule(s)

administered once daily to patients with MDD for 8 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No