Trial · NCT03193398
BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
NCT03193398, Phase 2, Completed, BlackThorn Therapeutics, Inc.; results first posted 2021-05-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder. Trials, record NCT03193398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03193398
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BTRX-246040 Administered Once Daily to Patients With Major Depressive Disorder
- NCT number
- NCT03193398
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 104 participants, actual
- Lead sponsor
- BlackThorn Therapeutics, Inc.
- Conditions
- Major Depressive Disorder
- Interventions
- BTRX-246040 oral capsule(s), Placebo oral capsule(s)
- First posted
- 2017-06-20
- Last updated
- 2026-11-04
- Results first posted
- 2021-05-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo | 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 | Change From Baseline in Investigator-administered MADRS-6 Total Score | 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. |
| Secondary | Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score | 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. |
| Secondary | Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score | 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. |
| Secondary | Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) | 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. |
| Secondary | Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator-administered MADRS-6 Total Score | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Investigator-administered Snaith-Hamilton Pleasure Scale (SHAPS) Score | Week 8 | The full analysis set (FAS) contained all patients in the randomized set who received at least 1 dose of study medication and had at least 1 post-dose efficacy assessment | Change in score on a scale from baseline | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo | BTRX-246040 | -15.0 | Standard Error 1.73 | Change in score on a scale from baseline | |
| Change in Investigator-administered MADRS Total Score From Baseline BTRX-246040 and Placebo | Placebo | -13.6 | Standard Error 1.79 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered MADRS-6 Total Score | BTRX-246040 | -10.7 | Standard Error 1.17 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered MADRS-6 Total Score | Placebo | -9.7 | Standard Error 1.21 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score | BTRX-246040 | -2.6 | Standard Error 0.67 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered HADS-A (Hospital Anxiety and Depression Scale - Anxiety Subscale) Score | Placebo | -3.5 | Standard Error 0.70 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score | BTRX-246040 | -5.0 | Standard Error 0.76 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered HADS-D (Hospital Anxiety and Depression Scale - Depression Subscale) Score | Placebo | -5.9 | Standard Error 0.80 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) | BTRX-246040 | 13.7 | Standard Error 16.7 | Change in score on a scale from baseline | |
| Change From Baseline in Investigator-administered Dimensional Anhedonia Rating Scale (DARS) | Placebo | 2.91 | Standard Error 3.04 | Change in score on a scale from baseline |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BTRX-246040 | 53 | |
| Overall Study | STARTED | Placebo | 51 | |
| Overall Study | COMPLETED | BTRX-246040 | 38 | |
| Overall Study | COMPLETED | Placebo | 35 | |
| Overall Study | NOT COMPLETED | BTRX-246040 | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events142
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | BTRX-246040 | 8 | 53 | |
| other | Headache | Nervous system disorders | Placebo | 13 | 51 | |
| other | Somnolence | Nervous system disorders | BTRX-246040 | 3 | 53 | |
| other | Somnolence | Nervous system disorders | Placebo | 7 | 51 | |
| other | Dizziness | Nervous system disorders | BTRX-246040 | 1 | 53 | |
| other | Dizziness | Nervous system disorders | Placebo | 2 | 51 | |
| other | Paraesthesia | Nervous system disorders | BTRX-246040 | 2 | 53 | |
| other | Paraesthesia | Nervous system disorders | Placebo | 0 | 51 | |
| other | Disturbance In Attention | Nervous system disorders | BTRX-246040 | 0 | 53 | |
| other | Disturbance In Attention | Nervous system disorders | Placebo | 1 | 51 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BTRX-246040 | 0 | 53 |
| Total, all-cause mortality | Placebo | 0 | 51 |
| Total, other adverse events | BTRX-246040 | 34 | 53 |
| Total, other adverse events | Placebo | 27 | 51 |
| Total, serious adverse events | BTRX-246040 | 0 | 53 |
| Total, serious adverse events | Placebo | 1 | 51 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BTRX-246040 vs Placebo: deaths from any cause | Trial comparisons |
| BTRX-246040 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03193398
GET https://conductscience.org/api/trials/v1/NCT03193398/events?page=2