ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03193398
Recruitment Status : Active, not recruiting
First Posted : June 20, 2017
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
BlackThorn Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: BTRX-246040 oral capsule(s) Drug: Placebo oral capsule(s) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Investigator-administered Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to Week 8 ]
    The change in MADRS total score between BTRX-246040 and placebo


Secondary Outcome Measures :
  1. Investigator-administered Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: The change from baseline to Week 8 ]
    The change in MADRS-6 subscale

  2. Investigator-administered Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: The change from baseline to Week 8 ]
    The change in MADRS individual items

  3. 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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193398


Locations
United States, California
United States
Cerritos, California, United States, 90703
United States
Garden Grove, California, United States, 92845
United States, Florida
United States, Florida
Jacksonville, Florida, United States, 32256
United States
Lauderhill, Florida, United States, 33319
United States, Florida
Orlando, Florida, United States, 32801
United States, Illinois
United States
Libertyville, Illinois, United States, 60048
United States, New York
United States
Rochester, New York, United States, 14618
United States, Tennessee
United States
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
BlackThorn Therapeutics, Inc.
Investigators
Study Director: Atul Mahableshwarkar, MD BlackThorn Therapeutics, Inc.

Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03193398     History of Changes
Other Study ID Numbers: NEP-MDD-201
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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