Major Depressive DisorderPhase 2JUNIPERNCT05536414
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
A Phase 2 study testing Centanafadine and Escitalopram in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 62 sites in United States.
Trial summary
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed 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?
- Centanafadine and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 62 sitesUnited States
- Study dates
- 12 Sep 2022to 16 May 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
- Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
- History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.
Who cannot join
- Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
- Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
- Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
- Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, 30331
MTP Psychiatry, LLC
Baltimore, Maryland, 21229-1506
The Memory Clinic
Bennington, Vermont, 05201-9810
Northwest Clinical Trials
Boise, Idaho, 83704-8638
Integrative Clinical Trials - Hunt - PPDS
Brooklyn, New York, 11229-3576
SPRI Clinical Trials, LLC - ERG - PPDS
Brooklyn, New York, 11235-5660
SanRo Clinical Research Group LLC
Bryant, Arkansas, 72022-9252
University of Virginia
Charlottesville, Virginia, 22903-9353
Flourish Research - Andersonville - PPDS
Chicago, Illinois, 60640-2831
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215-2123
University of Cincinnati
Cincinnati, Ohio, 45219-2498
Alpine Research Organization, Inc
Clinton, Utah, 84015-8563
CNS Clinical Research Group
Coral Springs, Florida, 33067-4644
FutureSearch Trials of Dallas, LLC - IVY - PPDS
Dallas, Texas, 75251
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, 30030-3438
InSite Clinical Research, LLC
DeSoto, Texas, 75115-2066
Cedar Clinical Research - IVY - PPDS
Draper, Utah, 84020-9884
Revive Research Institute
Elgin, Illinois, 60123-9215
Core Clinical Research
Everett, Washington, 98201-4077
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, 39232
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912-4367
Charak Clinical Research Center
Garfield Heights, Ohio, 44125-2946
Behavioral Research Specialists-California-Irvine
Glendale, California, 91206-4282
Houston Mind & Brain
Houston, Texas, 77055-6349
Innovative Medical Research of Texas
Houston, Texas, 77065-4776
Red Oak Psychiatry Associates P A
Houston, Texas, 77090-2607
University Hills Clinical Research
Irving, Texas, 75062-2762
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256-6040
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, 94549
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534-5504
Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, 91945-2956
Psych Atlanta
Marietta, Georgia, 30060-2585
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119-4806
South Florida Research Phase I - IV
Miami Springs, Florida, 33166-7225
LLM Research - South Carolina
Myrtle Beach, South Carolina, 29577-5898
Fieve Clinical Research
New York, New York, 10017-1945
Manhattan Behavioral Medicine
New York, New York, 10036-4543
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
North Canton, Ohio, 44720-1528
Behavioral Clinical Research, Inc
North Miami, Florida, 33161-5832
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368-8223
American Medical Research Inc
Oak Brook, Illinois, 60523-1818
Cutting Edge Research
Oklahoma City, Oklahoma, 73116-1423
ATP Clinical Research
Orange, California, 92866
NRC Research Institute - Orange - PPDS
Orange, California, 92868-2847
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801-2987
Accelerated Clinical Trials,LLC
Peachtree Corners, Georgia, 30071-2655
AIM Trials
Plano, Texas, 75093-8346
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, 97210-5354
Prospective Research Innovations
Rancho Cucamonga, California, 91730-4850
Anderson Clinical Research - ClinEdge - PPDS
Redlands, California, 92374-4555
Finger Lakes Clinical Research
Rochester, New York, 14618-1609
Lumos Clinical Research
San Jose, California, 95124-4108
Syrentis Clinical Research
Santa Ana, California, 92705-8675
Schuster Medical Research Institute
Sherman Oaks, California, 91403-1747
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71101-4603
Richmond Behavioral Associates
Staten Island, New York, 10314
University of South Florida
Tampa, Florida, 33613-4706
Viking Clinical Research Ltd
Temecula, California, 92591-5285
Bio Behavioral Health
Toms River, New Jersey, 08755-6434
Suburban Research Associates - ATLAS - West Chester - PPDS
West Chester, Pennsylvania, 19380-4370
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309-1608
Yuma CNS Research
Yuma, Arizona, 85365-4905
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).
The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.
- Conditions
- Major Depressive Disorder
- Being tested
- Centanafadine, Escitalopram, Placebo
- Keywords
- MDD, Centanafadine, SSRI, Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Behavioral Symptoms
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder, Depression, Mood Disorders, Mental Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentanafadineDrug
capsule
EscitalopramDrug
capsule
PlaceboDrug
capsule
| Study group | Role | What they receive |
|---|---|---|
| Centanafadine + Placebo | Experimental | Not described Receives: Drug: Centanafadine; Drug: Placebo |
| Centanafadine + Escitalopram | Experimental | Not described Receives: Drug: Centanafadine; Drug: Escitalopram |
| Escitalopram + Placebo | Active comparator | Not described Receives: Drug: Escitalopram; Drug: Placebo |
| Placebo + Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Measured: Baseline, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start12 Sep 2022
- Primary completion16 May 2025
- Study completion16 May 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 Otsuka Pharmaceutical Development & Commercialization, Inc.The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536414
- Sponsor's protocol ID
- 405-201-00062
- Acronym
- JUNIPER
- Status last verified
- May 2026
- First submitted
- 7 Sep 2022
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 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, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT05536414
- Acronym / sponsor ID
- JUNIPER / 405-201-00062
- Conditions
- Major Depressive Disorder
- Keywords
- MDD, Centanafadine, SSRI, Depressive Disorder, Depression, Depressive Disorder, Major, Mood Disorders, Mental Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 May 2025 (actual)
- First posted
- 10 Sep 2022 (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.
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).
The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Centanafadine + Placebo | Experimental | Drug: Centanafadine, Drug: Placebo |
| Centanafadine + Escitalopram | Experimental | Drug: Centanafadine, Drug: Escitalopram |
| Escitalopram + Placebo | Active comparator | Drug: Escitalopram, Drug: Placebo |
| Placebo + Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
- History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.
Key exclusion criteria (4 listed)
- Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
- Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
- Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
- Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.
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 |
|---|---|---|
| Centanafadinecapsule | Drug | Centanafadine + Escitalopram, Centanafadine + Placebo |
| Escitalopramcapsule | Drug | Centanafadine + Escitalopram, Escitalopram + Placebo |
| Placebocapsule | Drug | Centanafadine + Placebo, Escitalopram + Placebo, Placebo + Placebo |
Primary outcome
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Time frame: Baseline, Week 6
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 14 May 2026.
- Individual participant dataSharing planned: Yes. Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Related trials for Major Depressive Disorder
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
62 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 Centanafadine and Escitalopram in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 62 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 2 inclusion and 4 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 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 from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. (time frame: Baseline, Week 6). 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 14 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.