Clinical trial NCT03193398: BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Anhedonia
antidepressant
Nociceptin
NOPR
Lead sponsor: BlackThorn Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo
timeFrame: Week 8
Secondary outcomes:
measure: Change From Baseline in Investigator-administered MADRS-6 Total Score
timeFrame: Week 8
measure: Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score
timeFrame: Week 8
measure: Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score
timeFrame: Week 8
measure: Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)
timeFrame: Week 8
measure: Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score
timeFrame: Week 8
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: United States
state: California
city: Garden Grove
country: United States
facility: United States
state: California
city: Jacksonville
country: United States
facility: United States, Florida
state: Florida
city: Lauderhill
country: United States
facility: United States
state: Florida
city: Orlando
country: United States
facility: United States, Florida
state: Florida
city: Libertyville
country: United States
facility: United States
state: Illinois
city: Rochester
country: United States
facility: United States
state: New York
city: Memphis
country: United States
facility: United States
state: Tennessee
Study officials:
affiliation: BlackThorn Therapeutics, Inc.
name: Jane Tiller, MD
role: STUDY_DIRECTOR
References: