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NBI-1070770: Low Dose for Depression

Phase 2
Recruiting
Research Sponsored by Neurocrine Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to day 49
Awards & highlights

Study Summary

"This trial will test whether a new medication, NBI-1070770, is better than a placebo at reducing symptoms of depression in people with major depressive disorder."

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, common ones may include nausea, headache, dizziness, insomnia or sleepiness, changes in appetite, and potential mood swings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to day 49
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to day 49 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
Secondary outcome measures
Change in Total MADRS Score from Baseline at Postbaseline Timepoints

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: NBI-1070770: Medium DoseExperimental Treatment1 Intervention
Participants will receive medium-dose NBI-1070770.
Group II: NBI-1070770: Low DoseExperimental Treatment1 Intervention
Participants will receive low-dose NBI-1070770.
Group III: NBI-1070770: High DoseExperimental Treatment1 Intervention
Participants will receive high-dose NBI-1070770.
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo.

Find a Location

Who is running the clinical trial?

Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,679 Total Patients Enrolled
3 Trials studying Depression
656 Patients Enrolled for Depression
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,505 Total Patients Enrolled
2 Trials studying Depression
276 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment size of participants for this research?

"Indeed, the details on clinicaltrials.gov highlight the ongoing recruitment process for this trial. The study was initially posted on March 1st, 2024 and most recently updated on March 8th, 2024. A total of 72 participants are sought from two designated sites."

Answered by AI

Are individuals aged 55 and older eligible to participate in this trial?

"The trial is seeking individuals over 18 years of age but under the age of 65 to enroll as participants."

Answered by AI

What level of risk does the medium dose of NBI-1070770 pose to patients?

"Our team at Power rated the safety of NBI-1070770: Medium Dose as 2 on a scale from 1 to 3. This rating is due to its Phase 2 trial status, indicating some evidence supporting safety but lacking data confirming efficacy."

Answered by AI

Are new participants currently being accepted for this research study?

"Affirmative. Evidence from clinicaltrials.gov indicates that this study is currently seeking participants. The trial was initially published on March 1, 2024, and last revised on March 8, 2024. Researchers aim to enroll a total of 72 patients distributed across two designated centers."

Answered by AI

Which demographic is considered the most suitable for inclusion in this medical study?

"This research is open to enrolling 72 individuals aged between 18 and 65 who are grappling with depression. Specifically, applicants must present a primary diagnosis of either recurrent MDD or persistent MDD. Of significant importance, candidates currently undergoing pharmacological therapy for their depressive symptoms should have maintained this treatment regimen for no less than eight weeks before the screening process and express readiness to persist with the current antidepressant medication protocol. Moreover, potential participants need to demonstrate willingness and capability in adhering to all outlined study protocols and limitations."

Answered by AI
~48 spots leftby Sep 2025