SPT-300 for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of SPT-300 for individuals with major depressive disorder (MDD), a condition affecting mood and emotional well-being. Participants take SPT-300 capsules once daily for 42 days. The trial is open to those who have completed a previous study with this treatment and do not plan to become pregnant. Participants must also agree to avoid recreational drugs during the study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in MDD treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that SPT-300 is likely to be safe for humans?
Research has shown that SPT-300, also known as GlyphAllo, has been safe in earlier studies. Data from a past study indicated that SPT-300 was well-received by participants and had a good safety record, with most people not experiencing serious side effects. It also helps increase the body's levels of allopregnanolone, a compound that affects mood, without major safety issues.
While these results are promising, it's important to remember that this treatment is still under study. Ongoing research will continue to assess its safety and tolerability. Prospective participants should consult a healthcare professional to understand the implications of joining a trial.12345Why do researchers think this study treatment might be promising?
Researchers are excited about SPT-300 for depression because it may offer a novel approach to treatment. Most current treatments, like SSRIs and SNRIs, work by altering neurotransmitter levels, which can take weeks to show effects. SPT-300, however, might work faster by targeting a different pathway in the brain, potentially providing relief in just days. This could be a game-changer for those who need quicker results to manage their symptoms effectively.
What evidence suggests that SPT-300 might be an effective treatment for depression?
Research shows that SPT-300, also known as GlyphAllo, may help treat major depressive disorder (MDD). The main ingredient, allopregnanolone, has proven effective in other studies as a fast-acting antidepressant and anxiety reducer. Studies have found that SPT-300 reaches blood levels up to nine times higher than other oral forms of the same compound, potentially enhancing its effectiveness. These findings suggest that SPT-300 could be an effective treatment for people with depression, including those experiencing anxiety.15678
Who Is on the Research Team?
David Walling, Ph.D.
Principal Investigator
Collaborative Neuroscience Research - Garden Grove
Are You a Good Fit for This Trial?
This trial is for adults with major depressive disorder (MDD), which may include symptoms of anxiety. Participants must have completed a prior study with SPT-300 and shown that they can tolerate the medication without significant issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive SPT-300 capsules once daily for 42 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive SPT-300 to evaluate long-term safety and tolerability
What Are the Treatments Tested in This Trial?
Interventions
- SPT-300
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seaport Therapeutics
Lead Sponsor
Premier Research Group plc
Industry Sponsor
John Ratliff
Premier Research Group plc
Chief Executive Officer since 2024
MBA
Dr. Milena Kanova-Petrova
Premier Research Group plc
Chief Medical Officer since 2024
MD
Premier Research
Collaborator