NBI-1065845 for Depression

(SAVITRI Trial)

No longer recruiting at 48 trial locations

Overseen By Neurocrine Medical Information Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Neurocrine Biosciences

Must be taking: Antidepressants

Disqualifiers: Pregnancy, Neurological abnormalities, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, NBI-1065845, to evaluate its effectiveness for people with depression. Researchers aim to determine if this treatment can improve symptoms for those who haven't found success with current antidepressants. Participants will receive either a low dose, a high dose, or a placebo (a pill with no active medicine) to compare results. This trial suits individuals with major depression or persistent depressive disorder who haven't fully responded to previous treatments. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants currently on antidepressants must have been taking them for at least 8 weeks before the trial.

Is there any evidence suggesting that NBI-1065845 is likely to be safe for humans?

Studies have shown that NBI-1065845 is safe for humans. Research indicates that both low and high doses of NBI-1065845 caused side effects similar to those of a placebo, a non-active substance. Participants experienced side effects at rates similar to those who took a placebo. Importantly, no deaths or serious health problems occurred during the studies. This suggests that NBI-1065845 is well-tolerated and does not cause major health issues for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for depression?

Researchers are excited about NBI-1065845 because it offers a new approach to treating depression. Unlike standard treatments like SSRIs and SNRIs, which work by altering serotonin and norepinephrine levels, NBI-1065845 is thought to act on different brain pathways, potentially leading to faster and more effective relief from depressive symptoms. The treatment is available in both low and high-dose oral forms, providing flexibility and the possibility of tailoring to individual patient needs. This new mechanism and customizable dosing could mean a significant advancement in how we manage depression, offering hope to those who haven't found success with existing medications.

What evidence suggests that NBI-1065845 could be an effective treatment for depression?

Research has shown that NBI-1065845 may help treat major depressive disorder (MDD). Earlier studies found that it significantly improved depression symptoms, providing noticeable relief compared to a placebo. In this trial, participants will receive either a low or high dose of NBI-1065845. Both doses showed positive results in reducing depression symptoms in previous studies. Overall, evidence suggests that NBI-1065845 could be an effective option for managing depression. ^{1 2 3 4 6}

Who Is on the Research Team?

Clinical Development Lead

Principal Investigator

Neurocrine Biosciences

Are You a Good Fit for This Trial?

Adults aged 18-65 with Major Depressive Disorder (MDD) who haven't had enough improvement from previous antidepressant treatments can join. They must be on a stable depression medication for at least 8 weeks or have taken it for that long in their current episode. Pregnant or breastfeeding individuals, those with unstable health conditions, certain psychiatric disorders other than MDD, or a history of substance abuse cannot participate.

Inclusion Criteria

The subject has completed written informed consent.

Subject is currently on stable pharmacological treatment for depression.

The participant has completed written informed consent.

Exclusion Criteria

Participant is pregnant or breastfeeding or plans to become pregnant during the study.

Participant has an unstable medical condition or unstable chronic disease.

In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or NBI-1065845 (low or high dose) orally once a day

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NBI-1065845
• Placebo

Trial Overview The trial is testing the effectiveness of NBI-1065845 versus a placebo in improving symptoms of depression in adults with MDD. Participants will either receive the experimental drug NBI-1065845 or a placebo to compare outcomes between the two groups.

How Is the Trial Designed?

Group I: NBI-1065845 Low Dose Experimental Treatment 1 Intervention

Participants will receive low-dose NBI-1065845 orally once a day.

Group II: NBI-1065845 High Dose Experimental Treatment 1 Intervention

Participants will receive high-dose NBI-1065845 orally once a day.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally once a day.

Who Is Running the Clinical Trial?

Neurocrine Biosciences

Lead Sponsor

Trials

78

Recruited

6,600+

Kyle W. Gano

Neurocrine Biosciences

Chief Executive Officer since 2024

PhD in Pharmacology

Dr. Sanjay Keswani

Neurocrine Biosciences

Chief Medical Officer

MD

Published Research Related to This Trial

NSI-189, a neurogenic compound, was well tolerated in a Phase 1B study with 24 patients suffering from major depressive disorder, showing no serious adverse effects across multiple dosing regimens.

The treatment demonstrated promising efficacy, with significant reductions in depressive and cognitive symptoms measured by various scales, indicating potential as a new treatment option for MDD, although the study's small sample size is a limitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1B, randomized, double blind, placebo controlled, multiple-dose escalation study of NSI-189 phosphate, a neurogenic compound, in depressed patients. Fava, M., Johe, K., Ereshefsky, L., et al.[2022]

Aripiprazole augmentation for major depressive disorder (MDD) shows a remission rate of approximately 33% over long-term treatment (≥6 months), suggesting it can be an effective strategy for patients who do not respond to standard treatments.

Lower doses of aripiprazole (2-5 mg) are associated with fewer adverse effects, such as weight gain and akathisia, compared to higher doses (≥5 mg), making it a safer option for long-term management of MDD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Efficacy and Tolerability of Adjunctive Aripiprazole for Major Depressive Disorder: Systematic Review and Meta-analysis. Seshadri, A., Wermers, ME., Habermann, TJ., et al.[2021]

In a 12-week trial with 220 participants, NSI-189 at a 40 mg daily dose showed a significant reduction in depression symptoms on the Symptoms of Depression Questionnaire (SDQ) and Cognitive and Physical Functioning Scale (CPFQ) compared to placebo, suggesting potential efficacy in treating major depressive disorder.

Both doses of NSI-189 were well tolerated, indicating a favorable safety profile, and the findings support further investigation into its antidepressant and cognitive-enhancing effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder. Papakostas, GI., Johe, K., Hand, H., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06963021

NCT06963021 | NBI-1065845-MDD3026: Study to Assess ... The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of ...

2. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-positive-new-data-phase-2-study

Release Details - Neurocrine Biosciences Osavampator (NBI-1065845/TAK-653) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Depression Severity and is ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07196501

NCT07196501 | A Study to Evaluate the Maintenance ... The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying ...

4. prnewswire.com prnewswire.com/news-releases/neurocrine-biosciences-presents-positive-new-data-from-phase-2-study-of-osavampator-in-adults-with-major-depressive-disorder-302562476.html

Neurocrine Biosciences Presents Positive New Data from ... Osavampator (NBI-1065845/TAK-653) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Depression Severity and is ...

5. neurocrine.gcs-web.com neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-reports-positive-phase-2-data-nbi-1065845

Neurocrine Biosciences Reports Positive Phase 2 Data for ... This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/589058

Study to Assess the Efficacy and Safety of NBI-1065845 as ... ... Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD). Estimated trial completion date. Jul 1, 2027.