Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participant follows Placebo schedule (57 days) |
|
| Antidepressant | Experimental | Participant follows NBI-1065846 schedule (57 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Tablets for oral administration |
| |
| NBI-1065846 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57 | The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68. | Baseline, Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression | The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60. |
Not provided
Key Inclusion Criteria:
Participants must meet all of the following key inclusion criteria:
Completed written informed consent.
Aged 18 to 65 years, inclusive, at the time of informed consent.
Primary diagnosis of MDD.
Participants must meet one of the following criteria:
Snaith Hamilton Pleasure Scale (SHAPS) score is ≥30 at screening and Day 1.
Key Exclusion Criteria:
Participants will be excluded from the study if they meet any of the following key criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Lead | Neurocrine Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurocrine Clinical Site | Birmingham | Alabama | 35294 | United States | ||
| Neurocrine Clinical Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participant follows placebo schedule (57 days). |
| FG001 | NBI-1065846 | Participant follows NBI-1065846 schedule (57 days). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 21, 2023 | May 17, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Tablets for oral administration |
|
|
| Baseline, Day 57 |
| CGI-S Scores | The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. | Baseline and Day 57 |
| Garden Grove |
| California |
| 92845 |
| United States |
| Neurocrine Clinical Site | Lemon Grove | California | 91945 | United States |
| Neurocrine Clinical Site | Orange | California | 92868 | United States |
| Neurocrine Clinical Site | Riverside | California | 92506 | United States |
| Neurocrine Clinical Site | San Diego | California | 92103 | United States |
| Neurocrine Clinical Site | San Francisco | California | 94107 | United States |
| Neurocrine Clinical Site | Orlando | Florida | 32803 | United States |
| Neurocrine Clinical Site | Pensacola | Florida | 32502 | United States |
| Neurocrine Clinical Site | Winter Park | Florida | 32792 | United States |
| Neurocrine Clinical Site | Atlanta | Georgia | 30338 | United States |
| Neurocrine Clinical Site | Chicago | Illinois | 60641 | United States |
| Neurocrine Clinical Site | Skokie | Illinois | 60076 | United States |
| Neurocrine Clinical Site | Saint Charles | Missouri | 63304 | United States |
| Neurocrine Clinical Site | Raleigh | North Carolina | 27609 | United States |
| Neurocrine Clinical Site | Columbus | Ohio | 43210 | United States |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | 73112 | United States |
| Neurocrine Clinical Site | Dallas | Texas | 75235 | United States |
| Neurocrine Clinical Site | Friendswood | Texas | 77546 | United States |
| Neurocrine Clinical Site | Houston | Texas | 77030 | United States |
| Neurocrine Clinical Site | Murray | Utah | 84107 | United States |
| Neurocrine Clinical Site | Everett | Washington | 98201 | United States |
| Neurocrine Clinical Site | San Juan | 00926 | Puerto Rico |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Population: All randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participant follows placebo schedule (57 days). |
| BG001 | NBI-1065846 | Participant follows NBI-1065846 schedule (57 days). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Dimensional Anhedonia Rating Scale (DARS) Score | The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicated less anhedonia. All items were summed up to a total score in the range of 0 to 68. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Total Montgomery Ã…sberg Depression Rating Scale (MADRS) Score | The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranged from 0 to 60. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Clinical Global Impression - Severity (CGI-S) | The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57 | The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68. | Full Analysis Set (FAS): All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Day 57 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression | The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60. | FAS: All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Day 57 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | CGI-S Scores | The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. | FAS: All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure. Number analyzed = number of participants with evaluable data at the specified timepoint. | Posted | Count of Participants | Participants | Baseline and Day 57 |
|
|
Day 1 (after dosing) through Day 106
Safety Analysis Set: All randomized participants who took at least 1 dose of study treatment.
Participants were analyzed according to their randomized treatment group, unless they received the incorrect study treatment for the entire treatment duration.
Time frame includes treatment period (Days 1 to 57) and safety follow-up period (up to Day 106).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participant follows placebo schedule (57 days). | 0 | 47 | 1 | 47 | 4 | 47 |
| EG001 | NBI-1065846 | Participant follows NBI-1065846 schedule (57 days). | 0 | 46 | 0 | 46 | 3 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neurocrine Medical Information Call Center | Neurocrine Biosciences | 877-641-3461 | medinfo@neurocrine.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 16, 2023 | May 21, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D059445 | Anhedonia |
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C000721087 | TAK-041 |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| White |
|
| Other |
|
| Multiple |
|
|
|
|
|