Major Depressive DisorderPhase 2NCT03193398
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
A Phase 2 study testing BTRX-246040 oral capsule(s) in people with Major Depressive Disorder, run by BlackThorn Therapeutics, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- BTRX-246040 oral capsule(s)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 8 sitesUnited States
- Study dates
- 12 Jun 2017to 12 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
United States
Cerritos, California, 90703
United States
Garden Grove, California, 92845
United States, Florida
Jacksonville, Florida, 32256
United States
Lauderhill, Florida, 33319
United States
Libertyville, Illinois, 60048
United States
Memphis, Tennessee, 38119
United States, Florida
Orlando, Florida, 32801
United States
Rochester, New York, 14618
About this study
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
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
- Being tested
- BTRX-246040 oral capsule(s), Placebo oral capsule(s)
- Keywords
- Major Depressive Disorder, Anhedonia, antidepressant, Nociceptin, NOPR
- Medical subject headings
- Depressive Disorder, Major, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTRX-246040 oral capsule(s)Drug
BTRX-246040 administered once daily to patients with MDD for 8 weeks
Placebo oral capsule(s)Drug
administered once daily to patients with MDD for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo oral capsule(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 8
Secondary outcomes (5)
Change From Baseline in Investigator-administered MADRS-6 Total Score
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.
Measured: Week 8
Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score
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.
Measured: Week 8
Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score
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.
Measured: Week 8
Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)
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.
Measured: Week 8
Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start12 Jun 2017
- Primary completion12 Nov 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- BlackThorn Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jane Tiller, MD, Study director, BlackThorn Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193398
- Sponsor's protocol ID
- NEP-MDD-201
- Status last verified
- Oct 2026
- First submitted
- 19 Jun 2017
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03193398
- Acronym / sponsor ID
- NEP-MDD-201
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Anhedonia, antidepressant, Nociceptin, NOPR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BlackThorn Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTRX-246040 | Experimental | Drug: BTRX-246040 oral capsule(s)40 mg administered orally as 1 capsule QD for 1 week, followed by 80 mg as 2 capsules QD for 7 weeks. |
| Placebo | Placebo comparator | Drug: Placebo oral capsule(s)administered orally as 1 capsule QD for 1 week, followed by 2 capsules QD for 7 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BTRX-246040 oral capsule(s)BTRX-246040 administered once daily to patients with MDD for 8 weeks | Drug | BTRX-246040 |
| Placebo oral capsule(s)administered once daily to patients with MDD for 8 weeks | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Change From Baseline in Investigator-administered MADRS-6 Total Score
Time frame: Week 8
Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score
Time frame: Week 8
Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score
Time frame: Week 8
Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS)
Time frame: Week 8
Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Tiller, MD study director
BlackThorn Therapeutics, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BTRX-246040 oral capsule(s) in people with Major Depressive Disorder, run by BlackThorn Therapeutics, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.