NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Browse trials for

• Depressive Disorder, Major 3,041
• Depression 8,577

Keywords

• MDD
• Depression
• Major Depressive Disorder
• NBI-1065845
• TAK-653
• MADRS

Depressive Disorder, Major

3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.

This study's planned enrollment of 200 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.

Lead sponsor

Neurocrine Biosciences is the lead sponsor of 86 studies on the registry; 16 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Eligibility criteria

Study arms

• Experimental
  NBI-1065845

  NBI-1065845 administered orally once a day.

  Drug: NBI-1065845

• Placebo comparator
  Placebo

  Placebo identical in appearance to NBI-1065845 will be administered orally once a day.

  Drug: Placebo

Interventions

• DrugNBI-1065845

  NBI-1065845 tablets

  Also known as: TAK-653

• DrugPlacebo

  Matching placebo tablets

Primary outcomes

1. Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56

   Time frame: Baseline, Day 56

Secondary outcomes

1. Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56

   Time frame: Baseline, Day 56

2. Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56

   Time frame: Baseline, Day 56

Individual participant data

Plan to share: No