Now Enrolling · Clinical Research Study

Currently Enrolling: A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

RISE Institute is enrolling adults with depression in a clinical study evaluating whether NBI-1065845 can delay the return of depressive symptoms. Participation is voluntary and there is no cost to you.

See If I Qualify
Currently Enrolling · NBI-1065845 Study

The Study

What This Research Is About

This is a Phase 3, randomized, double-blind, placebo-controlled study sponsored by Neurocrine Biosciences. The study evaluates whether NBI-1065845 compared with placebo can delay the relapse of depressive symptoms (maintenance of effect) as an adjunctive treatment in participants with Major Depressive Disorder (MDD).

NBI-1065845 is an investigational medication taken orally once daily. Participants continue their current oral antidepressant medication at the same dose throughout the study — NBI-1065845 is taken in addition to, not instead of, existing treatment.

01
Evaluate the efficacy of NBI-1065845 compared with placebo in delaying the relapse of depressive symptoms (maintenance of effect)
02
Assess the duration of sustained response and time to relapse in participants with MDD
03
Evaluate the safety and tolerability of NBI-1065845 as a long-term adjunctive treatment

Eligibility

Who Can Participate

You may be eligible to participate if you meet the following key criteria:

  • 18 years of age or older
  • Primary diagnosis of recurrent Major Depressive Disorder (moderate or severe) or persistent depressive disorder
  • Inadequate response to oral antidepressant treatment in the current episode of depression
  • Currently taking oral antidepressants for at least 8 weeks and willing to continue the same medication at the same dose throughout the study
  • Able and willing to comply with all study procedures and restrictions

Additional inclusion and exclusion criteria apply. The study team will review your full eligibility during the screening process.

What's Involved

What to Expect

1

Check Your Eligibility

Complete a brief pre-screening with our team — by phone or virtually. There's no commitment at this stage, just a conversation to see if the study is a good fit for you.

2

Informed Consent

Our team walks you through everything — the study's purpose, what's involved, any risks, and your rights as a participant. You'll have all the time you need to ask questions before signing anything.

3

Study Visits

You'll attend regular visits with our study staff throughout the trial. You continue taking your current depression medication — NBI-1065845 is taken in addition to it, not instead of it. All study procedures and study medication are provided at no cost to you.

4

Follow-Up

After the active study period, our team will check in to monitor your wellbeing and gather final data. Your care doesn't stop when the visits do.

Compensation

You'll Be Compensated for Your Time

We value your time and commitment. All participants receive compensation for their time and study visits. Specific amounts will be communicated by the study team during the screening process.

Screening Visit
Compensated
Virtual pre-screening and in-person visit, inclusive
Study Visits
Compensated
All scheduled visits throughout the duration of the study
Meal Expenses
Reimbursed
Meal support provided for all in-person study visits
Travel support may also be available. You may be eligible for reimbursement of reasonable travel costs or arranged transportation where applicable. Details will be provided by the study team.

Your Rights

Participation Is Voluntary

Voluntary Participation

You can withdraw from the study at any time, for any reason, with no penalty and no impact on your care.

REB Oversight

This study has been reviewed and approved by a Research Ethics Board (REB) to ensure it meets all ethical standards.

Fully Informed

You'll never be asked to do anything without a complete explanation of what it involves, why, and what risks may exist.

Privacy Protected

Your personal and health information is handled in accordance with PIPEDA and all applicable Canadian privacy regulations.

Questions

Common Questions

No. This study uses an adjunctive treatment approach — you continue taking any depression medication you're currently on. NBI-1065845 is taken in addition to your existing treatment, not instead of it.
Study duration varies. Our team will provide a complete timeline before you make any commitment, so you know exactly what's involved upfront.
All studies at RISE Institute go through rigorous ethical review before enrollment begins, and participants are monitored closely throughout. As with any medical study, there may be risks — these will be disclosed to you in full during the consent process so you can make an informed decision.
Absolutely. Participation is entirely voluntary. You may withdraw at any stage without any impact on your access to other healthcare services or your relationship with RISE Institute.
Your data is stored securely and used only for research purposes. We comply with PIPEDA and all applicable Canadian and international research privacy standards.
You'll be assigned a dedicated study coordinator who is your point of contact from screening through follow-up. We're reachable by phone and email and committed to responding promptly.

Eligibility Pre-Screener

Let's See If This Study
Is Right for You

This short form takes about 2 minutes. It's not an enrollment — just the first step in starting a conversation with our team.

1 of 3 steps

Your Contact Information

We'll use this to reach you about your eligibility call. All fields marked * are required.

Please enter your first name.
Please enter your last name.
Please enter a valid email address.
Please enter your phone number.

Eligibility Criteria

Please check all that apply to you. You must meet all four criteria to be eligible for this study.

Preferred Call Times

Provide up to three windows when you're available for a 15–20 minute eligibility call with our team.

Please give us a date and time range for each slot — e.g., Tuesday May 6, between 10am–12pm. We'll confirm the exact time by email or phone.

By submitting this form, you agree to be contacted by the RISE Institute team regarding this study. Submitting does not enroll you in the study. Your information is kept confidential in accordance with PIPEDA.

You May Not Qualify for This Study

Based on your responses, you may not meet the eligibility criteria for this particular study. This doesn't mean you can't participate in future research.

If you believe you answered in error, or have questions about your eligibility, please reach out to our team directly.

Contact us at contact@riseinstitute.ca

You're on Your Way,

We've received your pre-screener and will be in touch within 1–2 business days to confirm your eligibility call time.

Check your inbox — we'll send a confirmation to .

Questions in the meantime? Email us at contact@riseinstitute.ca