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A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeurocrine Biosciences

About this trial

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.

Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.

Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.

Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).

Disqualifiers

A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.

Are considered by the investigator to be at imminent risk of suicide or injury to self or others.

Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NBI-1065845

    Drug

    Oral tablet

  • Placebo

    Drug

    Oral tablet

Treatment groups

550 Participants
are divided into 3 treatment groups
Group A: Open-label Treatment Period: NBI-1065845Experimental treatment 1 intervention
Group B: Randomized Double-blind Maintenance Period: NBI-1065845Experimental treatment 1 intervention
Group C: Randomized Double-blind Maintenance Period: PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from Randomization to Relapse

Time frame
From randomization to the earliest of relapse or end-of study (up to approximately 32 months)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Neurocrine Biosciences

Lead sponsor

Source ClinicalTrials.gov
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