Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNeurocrine Biosciences

About this trial

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment 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 prior to screening.

Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • NBI-1065845

    Drug

    NBI-1065845 tablets

Treatment groups

850 Participants
are divided into 1 treatment group
Group A: NBI-1065845Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Time frame
Baseline through Week 52

Secondary outcomes

Other outcomes

Sponsors and contacts

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