Major Depressive Disorder (MDD) MedDRA version: 21.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: SOC Classification code 10037175 Term: Psychiatric disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: NBI-1065845
Product Code: NBI-1065845
Pharmaceutical Form: Tablet
INN or Proposed INN: NBI-1065845
Current Sponsor code: NBI-1065845
Other descriptive name: TAK-653
Concentration unit: m
Sponsors
Neurocrine Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject has completed written informed consent. 2. At the time of signing the informed consent, subject must be 18 to 65 years of age, inclusive. 3. The subject has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder. 4. Subject must have had inadequate response to antidepressant treatment. 5. Total HAM-D17 score = 22 at screening. 6. Subjects currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for = 8 weeks prior to screening. Subjects not currently receiving pharmacological treatment for depression must have received the most recent antidepressant medication(s) for =8 weeks in the current episode of depression. 7. Subjects must be willing and able to comply with all study procedures and restrictions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1.Subject is pregnant or breastfeeding or plans to become pregnant during the study. 2.Subject has an unstable medical condition or unstable chronic disease. 3.Subject has a history of neurological abnormalities. 4.Subject has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD. 5.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT). 6.The subject has an alcohol or substance use disorder. 7.In the Investigator’s opinion, the subject is not capable of adhering to the protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of NBI-1065845 compared with placebo in subjects with MDD on improving symptoms of depression, as measured by the Montgomery Åsberg Depression Rating Scale (MADRS). ;Secondary Objective: • To evaluate the efficacy of NBI-1065845 compared with placebo in subjects with MDD on improving: o Overall severity of and improvement in depression o Depression response and remission rates, as measured by MADRS o Subject-rated depression severity • To assess for onset of antidepressant efficacy • To evaluate the safety and tolerability of NBI-1065845;Primary end point(s): Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28;Timepoint(s) of evaluation of this end point: Baseline, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 • Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56 • Response, defined as =50% decrease in MADRS from baseline, at Day 28 and Day 56 [ Time Frame: Baseline and Days 28 and 56 ] • Remission, defined as MADRS =10, at Days 28 and 56 [ Time Frame: Days 28 and 56 ] • Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Day 28 and Day 56;Timepoint(s) of evaluation of this end point: •For Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56 - Day 56 •For all others - Days 28 and 56 | — |
Countries
Bulgaria, Czechia, Czech Republic, Poland, Slovakia, Sweden, United States
Contacts
Public ContactNeurocrine Medical Information Call
Neurocrine Biosciences, Inc.
Outcome results
None listed