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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 belowSelect...
I am between 18 and 65 years old.
Select...
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:Select...
My blood pressure and diabetes are under control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 4, weeks 1, 2, 4, and 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 4, weeks 1, 2, 4, and 6
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.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 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Centanafadine + PlaceboExperimental Treatment2 Interventions
Group II: Centanafadine + EscitalopramExperimental Treatment2 Interventions
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
Centanafadine
2019
Completed Phase 2
~300
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
266 Previous Clinical Trials
168,776 Total Patients Enrolled
27 Trials studying Depression
38,983 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.I have tried an antidepressant that didn't work for me.My blood pressure and diabetes are under control.
Research Study Groups:
This trial has the following groups:- Group 1: Centanafadine + Placebo
- Group 2: Centanafadine + Escitalopram
- Group 3: Placebo + Placebo
- Group 4: Escitalopram + Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05536414 — Phase 2