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Fosigotifator for Depression

Phase 1
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current major depressive episode of at least 6 weeks to less than 24 months in duration at Screening (Visit 1)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 114 days

Summary

This trial is looking at a new treatment called fosigotifator for adults with major depressive disorder (depression). The study will involve around 106 participants from various locations. Participants will be randomly

Who is the study for?
This trial is for adults with Major Depressive Disorder as defined by the DSM-5, experiencing a depressive episode lasting 6 weeks to less than 2 years. Participants must need antidepressant therapy or be able to stop current medication safely for at least 7 days before starting the study drug.
What is being tested?
The trial tests Fosigotifator's safety and effectiveness against depression compared to a placebo. It's double-blinded, meaning neither doctors nor patients know who receives the actual drug or placebo. The treatment involves weekly visits, medical assessments, blood tests, side effect monitoring, and questionnaires.
What are the potential side effects?
Potential side effects of Fosigotifator are not specified but may include emotional changes like irritability, physical symptoms such as tiredness and aches, changes in eating habits due to its impact on mood disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been experiencing a major depressive episode for 6 weeks to less than 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 114 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 114 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Experiencing Adverse Events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FosigotifatorExperimental Treatment1 Intervention
Participants will receive fosigotifator.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive matching placebo for fosigotifator.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,029 Previous Clinical Trials
521,424 Total Patients Enrolled
6 Trials studying Depression
3,266 Patients Enrolled for Depression
ABBVIE INC.Study DirectorAbbVie
450 Previous Clinical Trials
161,910 Total Patients Enrolled
4 Trials studying Depression
2,456 Patients Enrolled for Depression
~71 spots leftby Nov 2026
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