A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder

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

300 Participants Needed

Trial Summary

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.

What safety data exists for the treatment evaluated under different names, including Placebo, Control, Dummy Treatment, SP-624?

In a study involving 430 healthy volunteers, the overall incidence of adverse events was 13.5%, with placebo treatments showing a 7.4% incidence. The most common adverse event was headache, and there were no deaths or life-threatening events reported. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new treatment called SP-624 to see if it is safe and effective for adults with Major Depressive Disorder. It aims to help those who haven't found relief with usual treatments by adjusting brain chemicals related to mood.

Research Team

Greg Rigdon, PhD

Principal Investigator

Sirtsei Pharmaceuticals, Inc.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Placebo
• SP-624

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

Analysis of pharmacology data and the prediction of adverse drug reactions and off-target effects from chemical structure. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. [2018]