Study to Assess the Efficacy and Safety of Adjunctive NBI-1065845 in Adults With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 21.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disordersMedDRA version: 20.0Level: SOCClassification code 10037175Term: Psychiatric disordersSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2021-003989-12-CZ
- Lead Sponsor
- eurocrine Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 212
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 Major Depressive Disorder (MDD), without psychotic features, meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria.
4.Subject must have had inadequate response to antidepressant
treatment.
5.Subject is currently on stable pharmacological treatment for depression.
6.Subject must have a total Hamilton Depression Rating Scale-17 Item (HAMD17) score = 22 at screening.
7.Subjects must have been taking current antidepressant medication(s) for = 8 weeks.
8.Subjects must be willing 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 211
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1.Subject is pregnant or breastfeeding.
2.Subject has an unstable medical condition or chronic disease.
3.Subject has a history of neurological abnormalities.
4.Subject is currently diagnosed with or prior diagnoses of psychiatric disorder which 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of NBI-1065845 compared with placebo used as adjunctive to oral antidepressants in subjects with MDD on improving symptoms of depression.;Secondary Objective: • To evaluate the efficacy of NBI-1065845 compared with placebo used as adjunctive to oral antidepressants in subjects with MDD on improving:<br>o Overall severity of and improvement in depression<br>o Depression response and remission rates, as measured by MADRS<br>o Subject-rated depression severity<br>o Quality of life <br>• To assess for onset of antidepressant efficacy <br>• To evaluate the safety and tolerability of NBI-1065845 used as adjunctive to oral antidepressant medication(s).;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: Day 28
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day<br>56<br>• Change from Baseline in Clinical Global Impression - Severity (CGI-S)<br>Score at Day 28 and Day 56<br>• Response, defined as =50% decrease in MADRS from baseline, at Day<br>28 and Day 56 [ Time Frame: Baseline and Days 28 and 56 ]<br>• Remission, defined as MADRS =10, at Days 28 and 56 [ Time Frame:<br>Days 28 and 56 ]<br>• Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Total<br>Score at Day 28 and Day 56<br>• Change from Baseline in Quality of Life outcomes (EQ-5D-5L VAS<br>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<br>•For all others - Days 28 and 56<br><br>