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Centanafadine for Depression (JUNIPER Trial)

Verified Trial
Phase 2
Recruiting
Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you between the ages of 18-65 years old
Have you had at least one inadequate response to an anti-depressant?
Must not have
Uncontrolled medical conditions such as blood pressure or diabetes?
Have you had any suicidal thoughts or actions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 4, weeks 1, 2, 4, and 6

Summary

This trial is testing a drug to treat Major Depressive Disorder in adults who haven't responded to other treatments. It will last 6 weeks and have 336 subjects in the United States.

Who is the study for?
Adults with Major Depressive Disorder who haven't had enough relief from 1-3 previous depression treatments can join this trial. It's not clear what excludes someone, but typically it would be things like other serious health issues or being on conflicting medications.
What is being tested?
The trial is testing Centanafadine as a standalone treatment or alongside Escitalopram (an SSRI) against a placebo. Participants will be randomly assigned to one of these groups and won't know which they're receiving during the 6-week study.
What are the potential side effects?
While specific side effects for Centanafadine aren't listed, common ones for antidepressants include nausea, sleep disturbances, fatigue, dry mouth, blurred vision, constipation, and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have tried an antidepressant that didn't work for me.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood pressure and diabetes are under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 4, weeks 1, 2, 4, and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, day 4, weeks 1, 2, 4, and 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Secondary study objectives
Change from baseline to Week 6 in Clinical Global Impression - Severity (CGI-S) score
Change from baseline to Week 6 in Patient Global Impression - Severity (PGI-S) score
Change from baseline to Week 6 in Symptoms of Major Depressive Disorder Scale (SMDDS) Total score
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + PlaceboExperimental Treatment2 Interventions
328.8 mg TDD will be administered as 2 x 164.4 mg XR capsules and 1 placebo XR capsule to be taken once daily in the morning.
Group II: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + EscitalopramExperimental Treatment2 Interventions
328.8 mg TDD will be administered as 2 x 164.4 mg XR capsules and 1 escitalopram XR capsule to be taken once daily in the morning.
Group III: Escitalopram + PlaceboActive Control2 Interventions
1 escitalopram XR capsule and 2 placebo XR capsules to be taken once daily in the morning.
Group IV: Placebo + PlaceboPlacebo Group1 Intervention
3 placebo XR capsules to be taken once daily in the morning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.Lead Sponsor
265 Previous Clinical Trials
170,188 Total Patients Enrolled
27 Trials studying Depression
38,983 Patients Enrolled for Depression

Media Library

Centanafadine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05536414 — Phase 2
Depression Research Study Groups: Placebo + Placebo, Escitalopram + Placebo, 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo, 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram
Depression Clinical Trial 2023: Centanafadine Highlights & Side Effects. Trial Name: NCT05536414 — Phase 2
Centanafadine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05536414 — Phase 2
Depression Patient Testimony for trial: Trial Name: NCT05536414 — Phase 2
~106 spots leftby Nov 2025
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