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


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This study is currently recruiting participants.

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Verified June 2017 by BlackThorn Therapeutics, Inc.

Sponsor:

Information provided by (Responsible Party):

BlackThorn Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT03193398

First received: June 19, 2017

Last updated: June 19, 2017

Last verified: June 2017

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.

Major Depressive Disorder Drug: BTRX-246040 oral capsule(s) Drug: Placebo oral capsule(s) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: 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

Primary Outcome Measures:

Secondary Outcome Measures:

  • Investigator-administered Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: The change from baseline to Week 8 ]

    The change in MADRS-6 subscale

  • Investigator-administered Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: The change from baseline to Week 8 ]

    The change in MADRS individual items

  • HADS subscales, the anxiety subscale (HADS-A) and the depression subscale (HADS-D) [ Time Frame: The change from baseline to Week 8 ]

    The change in total scores

  • Dimensional Anhedonia Rating Scale (DARS) [ Time Frame: The change from baseline to Week 8 ]
  • Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: The change from baseline to Week 8 ]

Estimated Enrollment: 100
Actual Study Start Date: June 12, 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Experimental: BTRX-246040

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)

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

Placebo Comparator: Placebo

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

Drug: Placebo oral capsule(s)

administered once daily to patients with MDD for 8 weeks

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, and have a HADS-D total score ≥ 11 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193398

United States, Florida
Jacksonville, Florida, United States, 32256
United States, Florida
Orlando, Florida, United States, 32801

BlackThorn Therapeutics, Inc.

Study Director: Annette Madrid, MD BlackThorn Therapeutics, Inc.

Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03193398     History of Changes
Other Study ID Numbers: NEP-MDD-201
Study First Received: June 19, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BlackThorn Therapeutics, Inc.:

Major Depressive Disorder
Anhedonia
antidepressant
Nociceptin
NOPR

Additional relevant MeSH terms:

Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on June 20, 2017