SP-624 for Depression

Not currently recruiting at 38 trial locations

Overseen By Yuki Prescott

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sirtsei Pharmaceuticals, Inc.

Must not be taking: Antidepressants, Mood stabilizers

Disqualifiers: Pregnancy, Uncontrolled hypertension, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SP-624 to determine its safety and effectiveness for people with Major Depressive Disorder. Participants will receive either SP-624 or a placebo (a pill with no active drug) to compare results. The study seeks adults diagnosed with moderate to severe depression who are in generally good physical health. The goal is to determine if SP-624 can improve depression symptoms better than a placebo. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in depression treatment.

Do I have to stop taking my current medications for this trial?

Yes, you will need to stop taking all psychoactive medications or supplements, including antidepressants and mood stabilizers, before starting the trial. The time you need to stop taking them will depend on how long it takes for the medication to leave your system.

Is there any evidence suggesting that SP-624 is likely to be safe for humans?

Research has shown that SP-624 underwent safety testing in earlier studies. Two studies examined how the body processes SP-624 and assessed its safety in healthy adults. These studies found that SP-624 was generally well-tolerated, with most participants not experiencing serious side effects.

Since this treatment is in Phase 2 trials, it has already passed initial safety tests in earlier phases. This suggests that SP-624 is likely safe for most people, but researchers continue to evaluate its effectiveness in treating major depressive disorder.

In summary, SP-624 appears safe based on earlier research. However, like any treatment, monitoring for side effects during the study remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Major Depressive Disorder?

SP-624 is unique because it introduces a potentially novel mechanism of action in treating Major Depressive Disorder. Unlike standard treatments like SSRIs and SNRIs, which primarily focus on altering serotonin and norepinephrine levels, SP-624 may target different pathways in the brain, offering a fresh approach to managing depression. Researchers are excited about this treatment as it could provide an alternative for patients who do not respond well to existing medications, potentially offering faster relief with fewer side effects. Additionally, its daily oral capsule form makes it convenient for patients to take regularly.

What evidence suggests that SP-624 could be an effective treatment for Major Depressive Disorder?

Research has shown that SP-624, a treatment in this trial, may help treat Major Depressive Disorder (MDD). In earlier studies, SP-624, which activates a protein called SIRT6, improved depression and cognitive function in women with MDD. Participants who took 20 mg daily for four weeks reported significant improvement compared to those on a placebo, the comparator in this trial. These results suggest that SP-624 might effectively reduce depression symptoms. Although more research is needed, these early findings offer promise for those considering this treatment. ^{2 4 5 6 7}

Who Is on the Research Team?

Greg Rigdon, PhD

Principal Investigator

Sirtsei Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must be experiencing symptoms of Major Depressive Disorder that are causing them significant distress or impairment in social, occupational, or other important areas of functioning

Women who could potentially get pregnant and men with partners who could potentially get pregnant must not have sex or use contraception for the entire study and for at least 30 days after the last dose of the study drug.

In generally good physical health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral capsules of SP-624 or placebo for the treatment of Major Depressive Disorder

5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SP-624

How Is the Trial Designed?

Group I: SP-624 Experimental Treatment 1 Intervention

Daily oral capsule, 20 mg/day

Group II: Placebo Placebo Group 1 Intervention

Daily oral capsule

Who Is Running the Clinical Trial?

Sirtsei Pharmaceuticals, Inc.

Lead Sponsor

Trials

4

Recruited

820+

Published Research Related to This Trial

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

The Annual Meeting of the Safety Pharmacology Society highlights the importance of assessing heart rate and blood pressure effects of candidate drugs in animal models like dogs and monkeys, which show good translation to human outcomes.

Innovative methodologies, such as video-tracking zebrafish behavior and comprehensive in vitro arrhythmia assays, are being developed to better identify drug-induced side effects, including those affecting non-vital organs, which can significantly impact patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

14th Annual Meeting of the Safety Pharmacology Society: threading through scientific sessions for originality and novelty. Cavero, I.[2018]

Romidepsin, an oncolytic drug previously abandoned due to serious cardiotoxicity, was successfully re-evaluated for clinical use by adjusting its dosing regimen to reduce cardiac risks, highlighting the importance of safety in drug development.

The integration of safety pharmacology endpoints into long-term toxicology studies can enhance the understanding of organ function during chronic drug exposure, suggesting a need for innovative approaches in safety assessments, such as the proposed Exploratory Safety Pharmacology (ESP) framework.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2012 Annual Meeting of the Safety Pharmacology Society: spotlight on targeted oncology medicines. Cavero, I.[2018]

In a review of 24 Phase I studies involving 430 healthy male volunteers over 5 years, the overall incidence of adverse events was 13.5%, with a higher rate for active drug treatments (15.3%) compared to placebo (7.4%).

Severe adverse events occurred in 20 cases (0.36%), but there were no deaths or life-threatening incidents, indicating that while adverse events are common, they are generally not severe in Phase I trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. Sibille, M., Deigat, N., Olagnier, V., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06254612

NCT06254612 | A Study of the Efficacy and Safety of SP ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41099447/

A Phase 2, multicenter, double-blind, randomized, placebo ... This phase 2 clinical study, SP-624-201, was designed to evaluate the safety and efficacy of forvisirvat 20 mg daily for 4 weeks in participants ...

3. hcplive.com hcplive.com/view/phase-2b-3-study-shows-promise-of-sp-624-improving-depression-cognition

Exploratory Study Shows Promise of SP-624 for Improving ... SP-624, a SIRT6 activator, showed promise in an exploratory study for treating depression and cognition in females with MDD.

4. tandfonline.com tandfonline.com/doi/full/10.1080/03007995.2025.2574465

A Phase 2, multicenter, double-blind, randomized, placebo ... Here we report results of the SP-624-201 phase 2 clinical study designed to evaluate safety and efficacy of forvisirvat in adults with MDD.

5. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/cpdd.1488

Phase 1, Single‐Center, Double‐Blind, Randomized, Placebo ... In SP-624-101 and SP-624-102, respectively, 3 (12%) and 5 (29%) SP-624–treated participants experienced treatment-emergent adverse events. SP- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04479852

A Study of the Safety and Efficacy of SP-624 ... This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-the-efficacy-and-safety-of-sp-624-in-the-treatment-of-adults-with-major-depressive-disord

A Study of the Efficacy and Safety of SP-624 in the Treatment ... 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 ...