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

NCT03193398 | Completed Phase 2 Results FDA Drug

• 1 other identifier: NEP-MDD-201
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 8

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Anhedonia; antidepressant; Nociceptin; NOPR

Outcome Measures

Primary Outcomes (1)

• Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo

  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.

  Week 8

Secondary Outcomes (5)

• 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

Study Arms (2)

BTRX-246040

EXPERIMENTAL

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

Drug: BTRX-246040 oral capsule(s)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule(s)

Interventions

BTRX-246040 oral capsule(s) DRUG

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

BTRX-246040

Placebo oral capsule(s) DRUG

administered once daily to patients with MDD for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BlackThorn Therapeutics, Inc.: lead

Study Sites (8)

United States

Cerritos, California, 90703, United States

Location

United States

Garden Grove, California, 92845, United States

Location

United States, Florida

Jacksonville, Florida, 32256, United States

Location

United States

Lauderhill, Florida, 33319, United States

Location

United States, Florida

Orlando, Florida, 32801, United States

Location

United States

Libertyville, Illinois, 60048, United States

Location

United States

Rochester, New York, 14618, United States

Location

United States

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anhedonia

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jane Tiller, MD; Study Director
• Organization: BlackThorn Therapeutics, Inc.

jane.tiller@blackthornrx.com

(415) 548-5313

Study Officials

• Jane Tiller, MD

  BlackThorn Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: June 12, 2017
• Primary Completion: November 12, 2018
• Study Completion: December 12, 2018
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)