Major Depressive DisorderPhase 2NCT06267846
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
A Phase 2 study testing NBI-1070770 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 13 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- NBI-1070770
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Mar 2024to 11 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Neurocrine Clinical Site
Dayton, Ohio, 45439
Neurocrine Clinical Site
Decatur, Georgia, 30030
Neurocrine Clinical Site
Gaithersburg, Maryland, 20877
Neurocrine Clinical Site
Hollywood, Florida, 33024
Neurocrine Clinical Site
Houston, Texas, 77008
Neurocrine Clinical Site
Lemon Grove, California, 91945
Neurocrine Clinical Site
Little Rock, Arkansas, 72211
Neurocrine Clinical Site
Long Beach, California, 90806
Neurocrine Clinical Site
Maitland, Florida, 32751
Neurocrine Clinical Site
North Canton, Ohio, 44730
Neurocrine Clinical Site
Richardson, Texas, 75080
Neurocrine Clinical Site
Rogers, Arkansas, 72758
Neurocrine Clinical Site
Savannah, Georgia, 31405
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder
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).
- Conditions
- Major Depressive Disorder
- Being tested
- NBI-1070770, Placebo
- Keywords
- Major Depressive Disorder, MDD, NBI-1070770, Neurocrine, Antidepressant, Depression, Montgomery-Åsberg Depression Rating Scale, MADRS
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI-1070770Drug
Suspension for oral administration
PlaceboDrug
Suspension for oral administration
| Study group | Role | What they receive |
|---|---|---|
| NBI-1070770: Low Dose | Experimental | Participants will receive low-dose NBI-1070770. Receives: Drug: NBI-1070770 |
| NBI-1070770: Medium Dose | Experimental | Participants will receive medium-dose NBI-1070770. Receives: Drug: NBI-1070770 |
| NBI-1070770: High Dose | Experimental | Participants will receive high-dose NBI-1070770. Receives: Drug: NBI-1070770 |
| Placebo | Placebo comparator | Participants will receive matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
Measured: Baseline, Day 5
Secondary outcomes (1)
Change in Total MADRS Score from Baseline at Postbaseline Timepoints
Measured: Baseline, up to Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2024
- Primary completion25 Jul 2025
- Study completion11 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Neurocrine BiosciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocrine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Lead, Study director, Neurocrine Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267846
- Sponsor's protocol ID
- NBI-1070770-MDD2029
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06267846
- Acronym / sponsor ID
- NBI-1070770-MDD2029
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, MDD, NBI-1070770, Neurocrine, Antidepressant, Depression, Montgomery-Åsberg Depression Rating Scale, MADRS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Neurocrine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NBI-1070770: Low Dose | Experimental | Drug: NBI-1070770Participants will receive low-dose NBI-1070770. |
| NBI-1070770: Medium Dose | Experimental | Drug: NBI-1070770Participants will receive medium-dose NBI-1070770. |
| NBI-1070770: High Dose | Experimental | Drug: NBI-1070770Participants will receive high-dose NBI-1070770. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NBI-1070770Suspension for oral administration | Drug | NBI-1070770: High Dose, NBI-1070770: Low Dose, NBI-1070770: Medium Dose |
| PlaceboSuspension for oral administration | Drug | Placebo |
Primary outcome
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
Time frame: Baseline, Day 5
1 secondary outcome
Change in Total MADRS Score from Baseline at Postbaseline Timepoints
Time frame: Baseline, up to Day 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Lead study director
Neurocrine Biosciences
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NBI-1070770 in people with Major Depressive Disorder, run by Neurocrine Biosciences at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5 (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.