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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 : Completed
First Posted : June 20, 2017
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 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
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : December 12, 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. Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo [ Time Frame: Week 8 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Investigator-administered MADRS-6 Total Score [ Time Frame: Week 8 ]
    The Investigator-administered MADRS-6 subscale focuses on the core symptoms of depression and assesses the following symptoms: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 36. The change from baseline in the Investigator-administered MADRS-6 subscale was analyzed using the same method as the MADRS efficacy endpoint, substituting the baseline MADRS-6 subscale as the covariate in place of the MADRS total score.

  2. Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score [ Time Frame: Week 8 ]
    The Investigator-administered Hospital Anxiety and Depression Scale (HADS) subscales comprises of 7 questions regarding Depression and 7 questions regarding Anxiety. Each question is rated on a scale from 0 - 3. The outcome of the HADS questionnaire is two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression.

  3. Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score [ Time Frame: Week 8 ]
    The Investigator-administered Hospital Anxiety and Depression Scale (HADS) subscales comprises of 7 questions regarding Depression and 7 questions regarding Anxiety. Each question is rated on a scale from 0 - 3. The outcome of the HADS questionnaire is two total scores, the HADS-A (for anxiety) and the HADS-D (for depression). Both total scores are graded on a scale of 0 - 21 and can be categorized as Normal (0 - 7), Borderline Abnormal (8 - 10) and Abnormal (11 - 21). Higher scores indicate higher levels of anxiety and depression.

  4. Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) [ Time Frame: Week 8 ]
    The Investigator-administered Dimensional Anhedonia Rating Scale (DARS) is a 17-item questionnaire with each answer between 0 and 4 on a Likert scale grading (0=Not at all, 1=Slightly, 2=Moderately, 3=Mostly, 4=Very Much). Therefore, the DARS total score is on a scale of 0 - 68. The DARS Total score is broken down into four dimensions; Hobbies, Food/Drink, Social Activities and Sensory Experience.

  5. Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score [ Time Frame: Week 8 ]
    The Investigator-administered Snaith Hamilton Pleasure Scale (SHAPS) is a 14-item questionnaire. The SHAPS is scored two different ways. Under the original scoring method, each question has 4 responses, 2 of which imply agreement (Definitely Agree, Agree; each scored as 0) and 2 which imply disagreement (Disagree, Strongly Disagree; each scored as 1). Therefore, the SHAPS total score ranges 0 - 14. In this study, in addition to the traditional scoring method, an alternative scoring method will assign 1 - Strongly Agree, 2 - Agree, 3 - Disagree, and 4 - Strongly Disagree. Using this alternative scoring method, the total score ranges 14-56. In both scoring systems, higher scores indicate greater anhedonia.



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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
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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
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Study Director: Jane Tiller, MD BlackThorn Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by BlackThorn Therapeutics, Inc.:
Study Protocol  [PDF] November 20, 2018
Statistical Analysis Plan  [PDF] December 6, 2018

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Responsible Party: BlackThorn Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03193398    
Other Study ID Numbers: NEP-MDD-201
First Posted: June 20, 2017    Key Record Dates
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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