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NCT06254612 · ClinicalTrials.gov registry record · Phase 2
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
A Phase 2 study of Major Depressive Disorder, sponsored by Sirtsei Pharmaceuticals.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 456
- Enrollment target
- 20
- Study locations
NCT06254612: Recruiting Phase 2 study of Major Depressive Disorder, sponsored by Sirtsei Pharmaceuticals.
NCT06254612 is a Phase 2 study of Major Depressive Disorder that is actively recruiting participants, run by Sirtsei Pharmaceuticals. The registered enrollment target is 456 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06254612, a Phase 2 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Sirtsei Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 456 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
Primary Outcome
The MADRS is a 10-item depression rating scale used to assess the severity of depression. Individual items are scored on a 7-point scale (0 to 6). The toal score is the sum of individual items, ranging from 0 to 60; where a higher score indicates more depression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SP-624
Study Locations (20)
California
- Clinical Innovations - Bellflower
- Sun Valley Research Center - Imperial
- Sunwise Clinical Research - Lafayette
- Synergy San Diego - Lemon Grove
- Excell Research - Oceanside
- CiTrials - Riverside
- Collaborative Neuroscience Research - Torrance
- Next Level Clinical Trials - West Covina
Florida
- Clinical Neuroscience Solutions - Jacksonville
- Accel Clinical - Lakeland
- Segal Trials - Lauderhill
- Segal Trials - Miami Lakes - Miami Lakes
- Clinical Neuroscience Solutions - Orlando
- DMI Research - Pinellas Park
Arizona
- IMA Clinical Research - Phoenix
- Noble Clinical Research - Tucson
Arkansas
- SanRo Clinical Research Group - Bryant
Colorado
- MCB Clinical Research Centers - Colorado Springs
Georgia
- Accelerated Enrollment Solutions - Atlanta
Idaho
- Velocity Clinical Research - Meridian
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 456 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What NCT06254612 shows while recruiting
NCT06254612 is an interventional study that assigns participants to a tested intervention. The registered 456 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (22% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06254612 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06254612 about?
NCT06254612 is a clinical study titled "A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder". This is a Phase 2B clinical study evaluating the effectiveness and safety of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.
What is the current status of trial NCT06254612?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 456 participants. The study started on 2024-03-25. Estimated completion is 2026-07-01.
What conditions does trial NCT06254612 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06254612?
The interventions under investigation include: Placebo (DRUG), SP-624 (DRUG).
Who is sponsoring clinical trial NCT06254612?
This trial is sponsored by Sirtsei Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06254612 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06254612's enrollment target sits among peer trials
456 41st of 282 higher than 242 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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