Assessing the safety of a new treatment for major depressive disorder
A Phase 1 b Randomized, Double-blind, Placebo-Controlled, Experimental Medicine Study of Fosigotifator in Adults With Major Depressive Disorder
This study is testing a new medication for major depressive disorder to see if it's safe and effective for adults struggling with this condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 4 sites (Sherman Oaks, California and 3 other locations) |
| Trial ID | NCT06618118 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of fosigotifator (ABBV-CLS-7262) in adults diagnosed with major depressive disorder (MDD). It is a double-blind, randomized trial where participants will receive either the treatment or a placebo, with a 50% chance of receiving each. Approximately 106 adult participants will be enrolled across 15 sites globally, and the study aims to gather data on adverse events associated with the new medication. Participants must meet specific criteria related to their depression and body mass index to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of major depressive disorder who meet specific inclusion criteria.
Not a fit: Patients with primary psychiatric illnesses other than major depressive disorder will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from major depressive disorder.
How similar studies have performed: Other studies have shown promise with similar approaches in treating major depressive disorder, but the specific treatment being tested is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body mass index of 18 to 33 kg/m2 at the time of consent. * Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for MDD based on the Structured Clinical Interview for DSM-5. * Current major depressive episode of at least 6 weeks to less than 24 months in duration at Screening (Visit 1 ). * Meets the following disease activity criteria mentioned in the protocol. * Requires antidepressant therapy (ADT) per the investigator's opinion or, if currently taking ADT, must be able to safely discontinue ADT at least 7 days prior to the first dose of study drug at Baseline (Visit 2). Exclusion Criteria: - Primary psychiatric illness other than MDD.
Where this trial is running
Sherman Oaks, California and 3 other locations
- CenExel CNR /ID# 265866 — Sherman Oaks, California, United States (Recruiting)
- Clinical Neuroscience Solutions - Orlando - East South Street /ID# 265060 — Orlando, Florida, United States (Recruiting)
- CenExel iResearch, LLC /ID# 265886 — Decatur, Georgia, United States (Recruiting)
- Northwest Clinical Research Center /ID# 265057 — Bellevue, Washington, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.