SPT-300 for Depression
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SPT-300, a potential antidepressant, for individuals with major depressive disorder (MDD), a condition marked by persistent sadness and loss of interest. The goal is to determine if SPT-300 can reduce depression symptoms, comparing it to a placebo (a pill with no active medicine). Individuals who have experienced a depressive episode for at least four weeks but less than 18 months, and who lack a history of treatment-resistant depression, may qualify. Participants must refrain from drug use and should not have significant other mental health conditions like bipolar disorder or obsessive-compulsive disorder. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.
Do I need to stop my current medications to join 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 trial coordinators or your doctor.
Is there any evidence suggesting that SPT-300 is likely to be safe for humans?
Research has shown that SPT-300 is generally safe for people. An earlier study found that most participants did not experience serious side effects when taking SPT-300, indicating a good safety record.
SPT-300 also increased levels of allopregnanolone, a natural brain steroid that can boost mood, more effectively than other oral forms. This suggests that the treatment works well in the body.
In summary, current evidence suggests that SPT-300 is safe for most people, with few serious issues reported.12345Why do researchers think this study treatment might be promising?
SPT-300 is unique because it uses a novel active ingredient that may offer a new approach to treating depression. Unlike traditional antidepressants, which often target serotonin or norepinephrine pathways, SPT-300 works differently, potentially offering benefits for patients who don't respond well to existing treatments. Researchers are excited about SPT-300 because it could provide faster relief from depressive symptoms and improved outcomes for individuals with treatment-resistant depression.
What evidence suggests that SPT-300 might be an effective treatment for major depressive disorder?
Research shows that SPT-300, also known as GlyphAllo, might help treat major depressive disorder (MDD). Studies have found that allopregnanolone, the main ingredient in SPT-300, works quickly to relieve depression and anxiety. Other trials have proven its effectiveness for these benefits. Additionally, SPT-300 reaches higher levels in the blood compared to similar treatments, which might enhance its effectiveness. This trial will compare SPT-300 to a placebo to evaluate its effectiveness. These findings suggest that SPT-300 could be a promising option for people dealing with depression.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 can include those who also experience anxiety. Participants should be diagnosed with MDD and fit the study's specific health requirements, but details on these are not provided here.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 or placebo capsules once daily for 42 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Collaborator
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