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SP-624 for Depression

Verified Trial
Phase 2
Waitlist Available
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).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 1-4 and 1- and 2- week follow-up
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 below
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I am between 18 and 65 years old.
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I have been diagnosed with moderate to severe depression.
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My doctor thinks I am in good physical health.
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My BMI is between 18 and 45.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 1-4 and 1- and 2- week follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 1-4 and 1- and 2- week follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
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.
+4 more

Trial 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
2 Previous Clinical Trials
327 Total Patients Enrolled
1 Trials studying Depression
300 Patients Enrolled for Depression
Rho, Inc.Industry Sponsor
24 Previous Clinical Trials
5,307 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for potential participants in this medical study, specifically excluding those under the age of 20?

"Individuals aged between 18 and 65 are eligible for enrollment in this clinical study. It is worth noting that there exist 221 trials targeted towards participants under the age of 18, as well as 1019 studies focusing on individuals over the age of 65."

Answered by AI

Is this medical study actively seeking participants at the moment?

"Information from clinicaltrials.gov shows that the investigation is not presently seeking subjects. It was originally posted on March 6th, 2024 and last updated on February 2nd, 2024. Despite this trial being inactive in recruitment, there are currently 1400 other trials actively enrolling participants."

Answered by AI

Is it possible for me to enroll as a participant in this medical study?

"This clinical investigation aims to enroll 456 individuals aged between 18 and 65 diagnosed with depression. Eligible participants must satisfy the following conditions: Fulfill DSM-5 standards for moderate to severe Major Depressive Disorder (MDD) as verified by the Mini International Neuropsychiatric Interview (MINI). Both males and females aged from 18 to 65 are eligible. Participants should be in satisfactory physical condition according to the Investigator's judgment. Body mass index (BMI) needs to fall within a range of ≥18 and ≤45 kg/m2."

Answered by AI

Has the FDA granted approval for SP-624?

"The safety evaluation of SP-624 by our team at Power rates a 2 on the scale due to its Phase 2 trial status, indicating some evidence supporting safety but lacking data on efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Emotional Fitness
Other
Segal Trials - Lauderhill, FL
Segal Trials - Miami Lakes, FL
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

What questions have other patients asked about this trial?

I'm interested in this trial, if compensation is available! I live here in Bellflower. Is it inpatient?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I'm hoping to find a medication that will get rid of my depression. Yes , I've mostly been on Zoloft, through the years. But have used Trazadone and Buspar aswell, without no significant result in my depression.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Segal Trials - Miami Lakes, FL: < 24 hours
  2. Segal Trials - Lauderhill, FL: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
2024. "A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06254612.
All > Depression Los Angeles > Greensboro
~304 spots leftby May 2025
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