Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI-1065845.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Bulgaria, Canada, Croatia +15
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Overview
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Interventions
- Drug NBI-1065845
NBI-1065845 tablets
Primary outcome measures
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Baseline through Week 52]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Other protocol defined inclusion and exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 46 centers
- Neurocrine Clinical Site — Huntsville
- Neurocrine Clinical Site — Bryant
- Neurocrine Clinical Site — Little Rock
- Neurocrine Clinical Site — Glendale
- Neurocrine Clinical Site — Los Angeles
- Neurocrine Clinical Site — Oceanside
- Neurocrine Clinical Site — Orange
- Neurocrine Clinical Site — Pico Rivera
- … and 38 more centers
Poland · 9 centers
Center list to be confirmed — check the primary protocol.
Bulgaria · 8 centers
- Neurocrine Clinical Site — Kardzhali
- Neurocrine Clinical Site — Plovdiv
- Neurocrine Clinical Site — Sofia
- Neurocrine Clinical Site — Sofia
- Neurocrine Clinical Site — Sofia
- Neurocrine Clinical Site — Sofia
- Neurocrine Clinical Site — Sofia
- Neurocrine Clinical Site — Varna
Slovakia · 6 centers
Center list to be confirmed — check the primary protocol.
Czechia · 5 centers
- Neurocrine Clinical Site — Pilsen
- Neurocrine Clinical Site — Prague
- Neurocrine Clinical Site — Prague
- Neurocrine Clinical Site — Prague
- Neurocrine Clinical Site — Prague
Latvia · 5 centers
- Neurocrine Clinical Site — Jelgava
- Neurocrine Clinical Site — Liepāja
- Neurocrine — Sigulda
- Neurocrine Clinical Site — Jelgava
- Neurocrine Clinical Site — Liepāja
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Finland · 3 centers
- Neurocrine Clinical Site — Kuopio
- Neurocrine Clinical Site — Oulu
- Neurocrine Clinical Site — Tampere
Netherlands · 3 centers
- Neurocrine Clinical Site — Amsterdam
- Neurocrine Clinical Site — Groningen
- Neurocrine Clinical Site — Leiden
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Belgium · 2 centers
- Neurocrine Clinical Site — Alken
- Neurocrine Clinical Site — Mechelen
Croatia · 2 centers
- Neurocrine Clinical Site — Zagreb
- Neurocrine Clinical Site — Zagreb
Lithuania · 2 centers
- Neurocrine Clinical Site — Kaunas
- Neurocrine Clinical Site — Kaunas
Taiwan · 2 centers
Center list to be confirmed — check the primary protocol.
Canada · 1 center
- Neurocrine Clinical Site — Toronto
Estonia · 1 center
- Neurocrine Clinical Site — Tallinn
Hungary · 1 center
- Neurocrine Clinical Site — Budapest
Italy · 1 center
- Neurocrine Clinical Site — Roma
Romania · 1 center
Center list to be confirmed — check the primary protocol.
Spain · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06966401 · NBI-1065845-MDD3028 · 2024-519423-24-00