NBI-1070770 for Depression

Recruiting at 12 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, Unstable conditions, Neurological, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

73 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the drug NBI-1070770 in treating symptoms of major depressive disorder (MDD). Researchers will assess the drug's effectiveness, safety, and tolerability at various doses compared to a placebo (a dummy pill with no active ingredients). The study includes groups receiving low, medium, or high doses of the drug, as well as a placebo group. It may suit individuals with recurring or ongoing depression who have been on antidepressants for at least 8 weeks and can maintain their current medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current antidepressant medications. Participants must continue with their current antidepressant medication(s) during the trial.

Is there any evidence suggesting that NBI-1070770 is likely to be safe for humans?

Research is testing the effectiveness and safety of NBI-1070770 for individuals with major depressive disorder (MDD). Earlier studies have shown that NBI-1070770 is generally well-tolerated, with no major safety concerns reported.

As this study is in an early stage, information on side effects remains limited. However, most participants have found the treatment manageable so far. Specific details on side effects are not yet available, but the study's progression to this phase suggests earlier results deemed it safe enough to continue.

Participants receive varying doses of NBI-1070770 to determine the most effective and safest amount. This approach helps identify and manage any possible side effects. ^{1 2 3 4 5}

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

NBI-1070770 is unique because it represents a potential new approach to treating depression. While most current treatments, like SSRIs and SNRIs, work by altering neurotransmitter levels over weeks, NBI-1070770 targets a different mechanism that researchers believe could yield faster results and might be effective for those who haven't responded well to traditional therapies. Additionally, the trial explores varying doses, which offers insights into optimizing effectiveness and minimizing side effects. Researchers are excited about this treatment because it could provide a new option for patients who need quicker relief or for whom existing medications aren't effective.

What evidence suggests that NBI-1070770 might be an effective treatment for depression?

Research has shown that NBI-1070770 targets a specific part of the brain involved in mood regulation, potentially aiding those with moderate to severe depression. Early results suggest that this focus could make NBI-1070770 effective at reducing depression symptoms. Although more information is needed, targeting this brain pathway holds promise for improving depression outcomes. This trial will compare different doses of NBI-1070770 to a placebo to confirm its effectiveness. ^{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?

This trial is for adults with recurrent or persistent Major Depressive Disorder (MDD) who've been on their current antidepressants for at least 8 weeks. They must be willing to continue these meds and follow all study rules.

Inclusion Criteria

I've been on my current antidepressants for 8 weeks or more and can keep taking them.

Participants must be willing and able to comply with all study procedures and restrictions

My condition is recurrent or persistent major depression.

Exclusion Criteria

Participant has an alcohol or substance use disorder

Participant is pregnant or breastfeeding or plan to become pregnant during the study

I have a chronic disease or medical condition that is not stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive NBI-1070770 or placebo to assess efficacy, safety, and tolerability in improving symptoms of depression

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-1070770

Trial Overview The trial tests NBI-1070770 against a placebo to see if it's better at improving depression symptoms in MDD patients. It measures how safe and tolerable the drug is compared to not receiving the active medication.

How Is the Trial Designed?

Group I: NBI-1070770: Medium Dose Experimental Treatment 1 Intervention

Participants will receive medium-dose NBI-1070770.

Group II: NBI-1070770: Low Dose Experimental Treatment 1 Intervention

Participants will receive low-dose NBI-1070770.

Group III: NBI-1070770: High Dose Experimental Treatment 1 Intervention

Participants will receive high-dose NBI-1070770.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive matching placebo.

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

In a study of 43 individuals with major unipolar depression, eight novel variants of the GAD67 gene were identified, but common genetic variations did not show a significant link to depression risk in a larger group of 103 depressed individuals compared to 125 controls.

The research indicates that while GAD67 is crucial for GABA synthesis in the brain, common genetic variations within this gene are unlikely to be a major factor in the predisposition to unipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mutation screen of the glutamate decarboxylase-67 gene and haplotype association to unipolar depression. Lappalainen, J., Sanacora, G., Kranzler, HR., et al.[2020]

Research indicates that abnormalities in GABA neurotransmission may play a significant role in the neurobiology of depression, with depressed individuals showing lower levels of GABA in plasma, cerebrospinal fluid, and the brain compared to non-depressed individuals.

Preclinical studies suggest that GABA-modulating agents can exhibit antidepressant effects, leading to increased interest in developing new antidepressant drugs that target GABAergic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GABAergic contributions to the pathophysiology of depression and the mechanism of antidepressant action. Sanacora, G., Saricicek, A.[2019]

Ketamine, an NMDA antagonist, has shown rapid improvement in depressive symptoms for patients who do not respond to traditional antidepressants, with effects lasting several days after a low-dose infusion.

A pilot study indicated that a higher-dose, 96-hour infusion of ketamine, combined with clonidine to reduce side effects, resulted in about 40% of subjects maintaining a good response for 8 weeks, highlighting the need for further research to optimize treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMDA Antagonists for Treatment-Resistant Depression. Farber, NB.[2019]

Major depressive disorder (MDD) is influenced by a complex interplay of various molecular pathways, including neurotransmitter systems, stress responses, neurogenesis, and inflammation, highlighting the multifaceted nature of the disease.

Understanding these interconnected pathways can enhance our comprehension of MDD's neurobiology and potentially lead to improved treatment strategies by focusing on synaptic activity as a key factor in mood and emotion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular pathways of major depressive disorder converge on the synapse. Fries, GR., Saldana, VA., Finnstein, J., et al.[2023]

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/NCT06267846

A Study to Evaluate the Efficacy and Safety of NBI-1070770 ... To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive ...

2. psychiatrictimes.com psychiatrictimes.com/view/first-patient-dosed-in-phase-2-clinical-trial-of-nbi-1070770-for-mdd

First Patient Dosed in Phase 2 Clinical Trial of NBI- ... The selectivity of NBI-1070770 for the NMDA NR2B receptor may benefit patients with moderate to severe depression.”

3. prnewswire.com prnewswire.com/news-releases/neurocrine-biosciences-announces-first-patient-dosed-in-phase-2-clinical-study-evaluating-nbi-1070770-in-adults-with-major-depressive-disorder-302106187.html

Neurocrine Biosciences Announces First-Patient Dosed in ... The study will evaluate the safety and efficacy of NBI-1070770 in subjects with major depressive disorder compared to placebo on improving symptoms of ...

4. withpower.com withpower.com/trial/phase-2-depressive-disorder-2-2024-9f6b8

NBI-1070770 for Depression · Info for Participants To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive ...

5. synapse.patsnap.com synapse.patsnap.com/article/neurocrine-begins-phase-2-trial-for-mdd-drug-nbi-1070770

Neurocrine Begins Phase 2 Trial for MDD Drug NBI-1070770 The primary objective is to assess the drug's safety and efficacy in alleviating depressive symptoms, as measured by the Montgomery-Åsberg ...

6. trialx.com trialx.com/clinical-trials/listings/285865/a-study-to-evaluate-the-efficacy-and-safety-of-nbi-1070770-in-adults-with-major-depressive-disorder/

A Study to Evaluate the Efficacy and Safety of NBI-1070770 ... To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive ...