A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
Summary
You are being asked to participate in this research study because you are at least 18 years of age, have been diagnosed with Major Depressive Disorder (MDD), and your depression symptoms have not improved with your current treatment. This investigational drug being studied for the treatment of depression is NBI-1065845. The use of NBI-1065845 to treat depression is not approved by the U.S. Food and Drug Administration (FDA), Health Canada (HC), or any other regulatory authority worldwide.
The purpose of this research study is to learn more about NBI-1065845 (study drug) by looking at:
• whether the study drug works to delay the return of depression symptoms.
• how well it helps to improve quality of life and the severity of depression symptoms.
• how safe it is and what side effects it causes.
Eligibility
Eligible ages: 18 to 60
Inclusion criteria:
Participants must meet the following inclusion criteria:
1. Completed informed consent.
2. ≥18 years of age at the time of signing the informed consent.
3. A primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
4. Must be feeling depressed
5. Must be receiving ≥1 oral antidepressant treatment(s) and must:
• Have been taking their current antidepressant medication(s) for ≥8 weeks prior to screening, AND
• Be willing to continue the same treatment at the same dose and frequency of administration throughout participation in the study,
6. Female subjects of childbearing potential must agree to use acceptable methods of contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.
Exclusion criteria:
Participants will be excluded from the study if they meet any of the following criteria:
1. A current or prior psychiatric disorder diagnosis in the last 1 year other than MDD (assessed by the MINI; e.g., eating disorder, schizophrenia, schizoaffective disorder, bipolar disorder, MDD with psychotic features or mixed features, moderate to severe substance use disorder); a comorbid personality disorder or a diagnosis of neurodegenerative disorders (including but not limited to dementias), intellectual disability, or mental disorders 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:
3. Unwilling to use contraceptives for duration of study
Participate
Additional information
Contact information
Dr. Stefanie Hassel
Principal investigator:
Valerie Taylor
Clinical trial:
Yes
REB-ID:
REB25-1315