Refer a Patient

Do You Have a Patient with Major Depressive Disorder (MDD) Who May Be Interested in the TERPSIS or SAVITRI Study?

If you have a patient with MDD whose current or past antidepressant medication(s) treatment regimen did not work well or did not improve their anhedonia, the TERPSIS or SAVITRI Study may be an option.

About the TERPSIS Study

Study Purpose

The purpose of the TERPSIS Study is to evaluate the safety and efficacy of a once-weekly oral investigational medication in participants with MDD who are on antidepressant medication(s) but are experiencing anhedonia.

Study Design

This research study is a phase 2, double-blind, placebo-controlled research study to evaluate the safety and efficacy of NBI-1065846 in the treatment of anhedonia. Participants will be randomized 1:1 to receive either the investigational medication or placebo and will be able to stay on their current antidepressant medication(s) while in the research study.

Study Participation

The total duration of the TERPSIS Study for each participant is approximately 20 weeks. This includes a 4-week screening period, 8-week treatment period, and 8-week follow-up period. There will be 6 on-site visits and 2 virtual visits with the study team throughout the research study.

Key Eligibility Criteria

Eligible participants must:

Be 18 to 65 years of age (inclusive)
Have a primary diagnosis of recurrent MDD (mild to severe, or in partial remission), persistent depressive disorder, or single episode MDD in remission
Be currently on or have previously been on stable pharmacological treatment for depression
Not be pregnant or breastfeeding or planning to become pregnant during the study
Not have a significant risk of suicidal or violent behavior, or exhibited any suicidal behavior in the 12 months before screening
- Participants must not have suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 12 months before screening

Additional eligibility criteria may apply.

About the SAVITRI Study

Study Purpose

The purpose of the SAVITRI Study is to evaluate whether a once-daily oral investigational medication is safe and improves symptoms of MDD in patients who are having an inadequate response to antidepressant medication(s).

Study Design

This research study is a phase 2, double-blind, placebo-controlled research study to evaluate whether the investigational medication NBI-1065845 is safe and improves symptoms of MDD. Participants will be randomized 1:1:2 to receive 1 of 2 doses of the investigational medication or the placebo and will be able to stay on their current antidepressant medication(s) while in the research study.

Study Participation

The total duration of the SAVITRI Study for each participant is approximately 14 weeks. This includes a 4-week screening period, 8-week treatment period, and 2-week follow-up period. There will be 8 visits with the study team throughout the research study.

Key Eligibility Criteria

Eligible participants must:

Be 18 to 65 years of age (inclusive)
Have a primary diagnosis of recurrent MDD (moderate, severe, or in partial remission) or persistent depressive disorder
Have had inadequate response to at least 1, but no more than 5, oral antidepressant medications administered in adequate courses (including the subjects current antidepressant treatment)
Be currently taking or have previously taken a stable treatment of an antidepressant medication(s)
Not be pregnant or breastfeeding or planning to become pregnant during the study
Not have a significant risk of suicidal or violent behavior, or exhibited any suicidal behavior in the 12 months before screening
- Participants must not have suicidal ideation of type 4 (active suicidal ideation with some intent to act, without specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS in the 12 months before screening

Additional eligibility criteria may apply.

Research Sites

If you have a patient who may be interested in participating in either the TERPSIS or SAVITRI Study and you think may qualify, refer your patient to this study website to take the prescreening questionnaire to determine eligibility, or fill out a contact request form if you would like to request contact directly from an active research site.

Find the Site Nearest You

Enter your zip/postal code below or click on the map to find the participating research site(s) nearest you.

Find sites for:

TERPSIS Study

SAVITRI Study

Zip/postal code

e.g., 12345

View full list of locations.

Active site locations

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