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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 up to 5 years
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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.
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Who is running the clinical trial?
Neurocrine BiosciencesLead Sponsor
75 Previous Clinical Trials
6,649 Total Patients Enrolled
3 Trials studying Depression
656 Patients Enrolled for Depression
Clinical Development LeadStudy DirectorNeurocrine Biosciences
24 Previous Clinical Trials
2,502 Total Patients Enrolled
2 Trials studying Depression
276 Patients Enrolled for Depression
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