Trial · NCT03051256
Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
NCT03051256, Phase 2, Completed, Relmada Therapeutics, Inc.; results first posted 2021-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD. Trials, record NCT03051256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03051256
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
- NCT number
- NCT03051256
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Relmada Therapeutics, Inc.
- Conditions
- Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant
- Interventions
- REL-1017, Placebo
- First posted
- 2017-02-13
- Last updated
- 2023-11-01
- Results first posted
- 2021-03-17
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | 21 days | Spontaneously reported or observed AEs will be recorded and reported throughout the study, and AEs will be elicited using a non-leading question at every visit from Screening through the Day 21 assessment. An AE was any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and may not necessarily have a causal relationship with the administered treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant laboratory abnormality, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, regardless of relationship to the medicinal (investigational) product. During the study, an AE could also occur outside the time that the investigational product(s) was given (e.g., during the time from discontinuation of prohibited medications). |
| Secondary | ECG Parameters [Safety] | Screening, Day -1, Day 1 hour 2, 8, Day 2 hour 2, 8, Day 3-7 hour 2, Day 8, Day 9, and Day 14 | 12-Lead ECGs will be performed and reported at Screening; at Check In (Day -1); Days 1 through 9; and at Day 14. |
| Secondary | Columbia Suicide Severity Rating Scale (C-SSRS) [Safety and Tolerability] | Day -1, Day 1, Day 2, Day 8, Day 9 and Day 14 | The C-SSRS will be administered and reported at Screening and Check In (Day -1); and at Days 1, 2, 8, 9 and 14. The C-SSRS is routinely used to quantify the severity of suicidal ideation and behavior. Both the ideation and behavior subscales are sensitive to change over time. The scale identifies behaviors that may be indicative of an individual's intent to commit suicide. This measure contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month. Each question addresses a different component of the respondent's suicide ideation severity: (1) Desire to be dead; (2) Suicidal thoughts; (3) Consideration of suicide methods; (4) Formed intent to commit suicide; (5) Completed suicide plan; and (6) Initiated suicide plan. A higher score indicates a higher intensity of suicidal ideation. |
| Secondary | Montgomery-Asberg Depression Scale (MADRS) | Change from Baseline to Day 7 | Montgomery-Asberg Depression Scale (MADRS) will be administered and reported on Days 4, 7, and 14. The MADRS questionnaire includes questions on the following symptoms: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. In Study REL-1017-202, the MADRS was administered using the Structured Interview Guide for the MADRS (SIGMA). A negative change from baseline indicates improvement. |
| Secondary | Montgomery-Asberg Depression Scale (MADRS) | Change from Baseline to Day 14 | Montgomery-Asberg Depression Scale (MADRS) will be administered and reported on Days 4, 7, and 14. The MADRS questionnaire includes questions on the following symptoms: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts. A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. In Study REL-1017-202, the MADRS was administered using the Structured Interview Guide for the MADRS (SIGMA). A negative change from baseline indicates improvement. |
| Secondary | Symptoms of Depression Questionnaire (SDQ) | Change from Baseline to Day 7 | Symptoms of Depression Questionnaire (SDQ) will be administered and reported on Days 4, 7, and 14. The SDQ is a 44-item, self-report scale designed to measure the severity of symptoms across several subtypes of depression. The SDQ was developed to more fully capture the heterogeneity of symptom presentations of depressive disorders than current, widely used scales for MDD. The SDQ includes items that inquire about an extensive number of depressive symptoms beyond the ones included in other commonly used scales. The 44 SDQ items are rated on a 6-point scale. The total score is the sum of 44 items and can range from 44 to 264. A negative change from baseline indicates improvement. 1 = Better than Normal; 2= Normal; 3= Minimally Sad; 4= Moderately Sad; 5= Markedly Sad; 6= Extremely Sad |
| Secondary | Symptoms of Depression Questionnaire (SDQ) | Change from Baseline to Day 14 | Symptoms of Depression Questionnaire (SDQ) will be administered and reported on Days 4, 7, and 14. The SDQ is a 44-item, self-report scale designed to measure the severity of symptoms across several subtypes of depression. The SDQ was developed to more fully capture the heterogeneity of symptom presentations of depressive disorders than current, widely used scales for MDD. The SDQ includes items that inquire about an extensive number of depressive symptoms beyond the ones included in other commonly used scales. The 44 SDQ items are rated on a 6-point scale. The total score is the sum of 44 items and can range from 44 to 264. A negative change from baseline indicates improvement. 1 = Better than Normal; 2= Normal; 3= Minimally Sad; 4= Moderately Sad; 5= Markedly Sad; 6= Extremely Sad |
| Secondary | Clinical Global Impressions of Severity (CGI-S) | Change from Baseline to Day 7 | Clinical Global Impressions of Severity (CGI-S) will be administered and reported on Days 4, 7, and 14. The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression. |
| Secondary | Clinical Global Impressions of Severity (CGI-S) | Change from Baseline to Day 14 | Clinical Global Impressions of Severity (CGI-S) will be administered and reported on Days 4, 7, and 14. The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression. |
| Secondary | Clinical Global Impressions of Improvement (CGI-I) | Change from Baseline to Day 7 | Clinical Global Impressions of Improvement (CGI-I) will be administered and reported at Days 4, 7 and 14. The CGI-I is a standard method used in clinical studies to quantify and track patient change over time. The scale is composed of 7 ratings: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The score ranges from 1 to 7, and a lower CGI-I score indicates greater improvement in symptoms. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | 21 days | Safety population: All randomized patients who received any study treatment (REL-1017 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | ECG Parameters [Safety] | Screening, Day -1, Day 1 hour 2, 8, Day 2 hour 2, 8, Day 3-7 hour 2, Day 8, Day 9, and Day 14 | Safety population: All randomized patients who received any study treatment (REL-1017 or placebo). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Columbia Suicide Severity Rating Scale (C-SSRS) [Safety and Tolerability] | Day -1, Day 1, Day 2, Day 8, Day 9 and Day 14 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Montgomery-Asberg Depression Scale (MADRS) | Change from Baseline to Day 7 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Montgomery-Asberg Depression Scale (MADRS) | Change from Baseline to Day 14 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Symptoms of Depression Questionnaire (SDQ) | Change from Baseline to Day 7 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Symptoms of Depression Questionnaire (SDQ) | Change from Baseline to Day 14 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions of Severity (CGI-S) | Change from Baseline to Day 7 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions of Severity (CGI-S) | Change from Baseline to Day 14 | ITT Population | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Clinical Global Impressions of Improvement (CGI-I) | Change from Baseline to Day 7 | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group204
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | REL-1017 25 mg | All-causality TEAEs | 9 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | REL-1017 50 mg | All-causality TEAEs | 15 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | Placebo | All-causality TEAEs | 12 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | REL-1017 25 mg | All-causality SAEs | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | REL-1017 50 mg | All-causality SAEs | 0 | Participants | |
| Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability] | Placebo | All-causality SAEs | 0 | Participants | |
| ECG Parameters [Safety] | REL-1017 25 mg | Screening / Normal | 14 | Participants | |
| ECG Parameters [Safety] | REL-1017 50 mg | Screening / Normal | 19 | Participants | |
| ECG Parameters [Safety] | Placebo | Screening / Normal | 16 | Participants | |
| ECG Parameters [Safety] | REL-1017 25 mg | Screening / Abnormal (not clinically significant) | 5 | Participants |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | REL-1017 25 mg | 19 | |
| Overall Study | STARTED | REL-1017 50 mg | 21 | |
| Overall Study | STARTED | Placebo | 22 | |
| Overall Study | COMPLETED | REL-1017 25 mg | 19 | |
| Overall Study | COMPLETED | REL-1017 50 mg | 21 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | REL-1017 25 mg | 0 | |
| Overall Study | NOT COMPLETED | REL-1017 50 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events93
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 | Constipation | Gastrointestinal disorders | REL-1017 25 mg | 1 | 19 | 1 |
| other | Constipation | Gastrointestinal disorders | REL-1017 50 mg | 3 | 21 | 3 |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 22 | 3 |
| other | Nausea | Gastrointestinal disorders | REL-1017 25 mg | 1 | 19 | 1 |
| other | Nausea | Gastrointestinal disorders | REL-1017 50 mg | 2 | 21 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 22 | 2 |
| other | Diarrhea | Gastrointestinal disorders | REL-1017 25 mg | 0 | 19 | 0 |
| other | Diarrhea | Gastrointestinal disorders | REL-1017 50 mg | 0 | 21 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 22 | 3 |
| other | Abdominal Discomfort | Gastrointestinal disorders | REL-1017 25 mg | 0 | 19 | 0 |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | REL-1017 25 mg | 0 | 19 |
| Total, all-cause mortality | REL-1017 50 mg | 0 | 21 |
| Total, all-cause mortality | Placebo | 0 | 22 |
| Total, other adverse events | REL-1017 25 mg | 9 | 19 |
| Total, other adverse events | REL-1017 50 mg | 15 | 21 |
| Total, other adverse events | Placebo | 12 | 22 |
| Total, serious adverse events | REL-1017 25 mg | 0 | 19 |
| Total, serious adverse events | REL-1017 50 mg | 0 | 21 |
| Total, serious adverse events | Placebo | 0 | 22 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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