A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

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Neurocrine Biosciences

Status and phase

Enrolling
Phase 2

Conditions

Major Depressive Disorder

Treatments

Drug: Placebo
Drug: NBI-1070770

Study type

Interventional

Funder types

Industry

Identifiers

NCT06267846
NBI-1070770-MDD2029

Details and patient eligibility

About

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Enrollment

72 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

  • Primary diagnosis of recurrent MDD or persistent MDD.
  • Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
  • Participants must be willing and able to comply with all study procedures and restrictions.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

  • Participant is pregnant or breastfeeding or plan to become pregnant during the study.
  • Participant has an unstable medical condition or unstable chronic disease.
  • Participant has a history of neurological abnormalities.
  • Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
  • Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
  • Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

72 participants in 4 patient groups, including a placebo group

NBI-1070770: Low Dose
Experimental group
Description:
Participants will receive low-dose NBI-1070770.
Treatment:
Drug: NBI-1070770
NBI-1070770: Medium Dose
Experimental group
Description:
Participants will receive medium-dose NBI-1070770.
Treatment:
Drug: NBI-1070770
NBI-1070770: High Dose
Experimental group
Description:
Participants will receive high-dose NBI-1070770.
Treatment:
Drug: NBI-1070770
Placebo
Placebo Comparator group
Description:
Participants will receive matching placebo.
Treatment:
Drug: Placebo

Trial contacts and locations

12

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Central trial contact

Neurocrine Medical Information Call Center

Data sourced from clinicaltrials.gov

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