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SP-624 for Depression
Verified Trial
Phase 2
Recruiting
Research Sponsored by Sirtsei Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females, aged 18 to 65 years, inclusive.
Meet DSM-5 criteria for moderate to severe MDD, as confirmed by the Mini International Neuropsychiatric Interview (MINI).
Must not have
You have been diagnosed with HIV (Human Immunodeficiency Virus)
Timeline
Screening 3 weeks
Treatment 4 weeks
Follow Up baseline to weeks 1-4 and 1- and 2- week follow-up
Summary
"This trial is testing if SP-624 is better than a placebo in treating adults with Major Depressive Disorder."
Who is the study for?
Adults aged 18 to 65 with moderate to severe Major Depressive Disorder (MDD) as per DSM-5 criteria can join this trial. Participants should be in good health overall and have a BMI between ≥18 and ≤45 kg/m2.
What is being tested?
The trial is testing the effectiveness of SP-624 against a placebo for treating MDD. It's a Phase 2B study, which means it's looking at how well SP-624 works and checking its safety.
What are the potential side effects?
While specific side effects of SP-624 are not listed, common ones for depression medications may include nausea, weight changes, drowsiness, dry mouth, increased sweating or sexual side effects.
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 been diagnosed with moderate to severe depression.
Select...
My doctor thinks I am in good physical health.
Select...
My BMI is between 18 and 45.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 3 weeks3 visits
Treatment ~ 4 weeks8 visits
Follow Up ~ baseline to weeks 1-4 and 1- and 2- week follow-up
Screening ~ 3 weeks
Treatment ~ 4 weeks
Follow Up ~baseline to weeks 1-4 and 1- and 2- week follow-up
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 in 17-item-Hamilton Depression Rating Scale (HAM-D-17) total score.
Change from Baseline in Quick Inventory of Depressive Symptomology-Self-Report (QIDS-SR) total score.
Change from Baseline in Sheehan Disability Scale (SDS) total score.
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SP-624Experimental Treatment1 Intervention
Participants to receive two 10 mg capsules of SP-624 once daily for a total daily dose of 20 mg
Group II: PlaceboPlacebo Group1 Intervention
Participant to receive 2 matching placebo capsules once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SP-624
2020
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Sirtsei Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
363 Total Patients Enrolled
2 Trials studying Depression
336 Patients Enrolled for Depression
Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,309 Total Patients Enrolled
1 Trials studying Depression
132 Patients Enrolled for Depression
Greg Rigdon, PhDStudy DirectorSirtsei Pharmaceuticals, Inc.
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Depression
300 Patients Enrolled for Depression