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

Completed · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT03193398

Run by

BlackThorn Therapeutics, Inc.

People needed

104

Starts

2017-06-12

Expected to finish

2018-12-12

Last updated by the study team

2021-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• United States — Cerritos, California, United States
• United States — Garden Grove, California, United States
• United States, Florida — Jacksonville, Florida, United States
• United States — Lauderhill, Florida, United States
• United States, Florida — Orlando, Florida, United States
• United States — Libertyville, Illinois, United States
• United States — Rochester, New York, United States
• United States — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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