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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
Awards & highlights
JUNIPER Trial 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.Check my eligibility
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.See study design
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.
JUNIPER Trial 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.
JUNIPER Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
Secondary outcome measures
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 moreJUNIPER 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
246 Previous Clinical Trials
166,713 Total Patients Enrolled
28 Trials studying Depression
39,883 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: Placebo + Placebo
- Group 2: Escitalopram + Placebo
- Group 3: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Placebo
- Group 4: 328.8 mg dose Total Daily Dose (TDD) Centanafadine + Escitalopram
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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enrolled in this research project?
"Indeed, the details on clinicaltrials.gov show that this medical investigation is actively recruiting patients. It was first posted in September 12th 2022 and most recently updated on the 14th of said month; 336 participants from a single site are sought after."
Answered by AI
Am I eligible to join this research endeavor?
"This clinical trial is open to 336 patients aged between 18 and 65 who have a major depressive disorder diagnosis. Further, the participants must meet specified additional criteria in order to qualify for inclusion."
Answered by AI
What health risks does Centanafadine (328.8 mg) pose to individuals?
"Centanafadine (328.8 mg) was deemed a 2 on the safety scale, as this is a Phase 2 trial with data suggesting it's safe but no evidence to support its efficacy yet."
Answered by AI
Are there any open opportunities to participate in this experimentation?
"Indeed, the research posted on clinicaltrials.gov confirms that this study is currently seeking participants. It was initially shared on September 12th 2022 and has since been updated once, as of September 14th 2022. This investigation requires 336 patients to be enrolled from a single medical facility."
Answered by AI
Does the criteria for this trial include individuals that are younger than 25 years old?
"This study seeks participants who are of legal age and under 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Other
Virginia
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Research Site - Shreveport, LA
For additional information regarding sites, contact 844-687-8522
Research Site - Maryland
How many prior treatments have patients received?
0
1
2
3+
Why did patients apply to this trial?
to find treatment. I’ve tried 17 drugs that some worked but most didn’t. I've tried many different drugs over the years, and right now, I'm just not doing that great.
PatientReceived 2+ prior treatments
I have tried 5 other medications that didn't work and so I'm hoping this medication will work.
PatientReceived 2+ prior treatments
I've tried over 15 medications since 2000. I want to help find a medication that will help others like me.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long does the screening take? How long do screening visits take? How long are visits to the facility?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Research Site - Maryland: < 48 hours
Average response time
- < 2 Days
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