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Study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)
EU CTIS ID: 2024-519418-29-00
What this study is testing
The primary objective for this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in subjects with MDD on improving symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Completed informed consent.
- 2.≥18 years of age at the time of signing the informed consent.
- 4.The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. The MDD diagnosis must be confirmed using the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
- 5.The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.
- 6.Subject must have an Inadequate Response (IR) to oral antidepressant treatments that were administered as adequate courses (dose, duration, adherence) in the current episode of depression, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
- 7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
You likely can't join if
- 1.A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that has been evident outside of depressive episodes or that may interfere with participation in the study; or a diagnosis of neurodegenerative disorder (including but not limited to dementia), eating disorder (except binge eating disorder), schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, intellectual disability, or mental disorder due to a general medical condition as defined in DSM-5.
- 2.Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- 6.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
- 9.Pregnant (ie, positive pregnancy test at screening or baseline) or lactating or plans to become pregnant during the study.
- 10.An unstable medical condition or unstable chronic disease (including history of neurological [including cognitive impairment, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) within 3 months before Day 1, or malignancy within 6 months before Day 1.
- 11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.
See the full eligibility criteria
Who can join
- 1. Completed informed consent.
- 2.≥18 years of age at the time of signing the informed consent.
- 4.The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder. The MDD diagnosis must be confirmed using the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
- 5.The subject must be receiving oral antidepressant treatment(s) as defined in the protocol.
- 6.Subject must have an Inadequate Response (IR) to oral antidepressant treatments that were administered as adequate courses (dose, duration, adherence) in the current episode of depression, as assessed using the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ).
- 7.Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
- 13. Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
What rules you out
- 1.A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that has been evident outside of depressive episodes or that may interfere with participation in the study; or a diagnosis of neurodegenerative disorder (including but not limited to dementia), eating disorder (except binge eating disorder), schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, intellectual disability, or mental disorder due to a general medical condition as defined in DSM-5.
- 2.Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
- 6.The subject’s depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
- 9.Pregnant (ie, positive pregnancy test at screening or baseline) or lactating or plans to become pregnant during the study.
- 10.An unstable medical condition or unstable chronic disease (including history of neurological [including cognitive impairment, myasthenia gravis], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results) within 3 months before Day 1, or malignancy within 6 months before Day 1.
- 11.Any laboratory abnormality suggestive of clinically significant, poorly or unmanaged, undiagnosed disease.
- 12.History of epilepsy, seizures, or convulsions
- 13.History of neurological abnormalities including brain injury (including traumatic injury), perinatal cerebropathy, and postnatal brain damage, blood- brain barrier abnormality, and cavernous angioma.
- 20. Any reason that makes the subject unsuitable for participation in this study (eg, subject is homeless, known to have difficulty complying with treatment or medical procedures, known to provide inaccurate medical information, or known to attempt participation in clinical trials inappropriately) per the investigator, Medical Monitor, and/or Sponsor.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.