Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547489
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Randomized Double-blind Evaluation of the Efficacy and Safety of Oral GATE-251 or Placebo for the Reduction of Symptoms of Major Depressive Disorder in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if GATE-251 works to treat depression in adults It will also learn about the safety of GATE-251 The main questions it aims to answer are
Does GATE-251 reduce depression scores in participants compared to participants who take a placebo a look-alike tablet that contains no GATE-251
What medical problems are observed in participants who take GATE-251
Participants will take one tablet of GATE-251 or placebo every week for 6 weeks Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated
Does GATE-251 reduce depression scores in participants compared to participants who take a placebo a look-alike tablet that contains no GATE-251
What medical problems are observed in participants who take GATE-251
Participants will take one tablet of GATE-251 or placebo every week for 6 weeks Participants will visit the clinic every week of the 6 week period to have the severity of their depression evaluated
Detailed Description:
This is a Phase 2 multicenter randomized double-blind placebo-controlled parallel-group fixed dose clinical trial designed to evaluate the safety and efficacy of GATE-251 versus placebo in subjects with symptoms of major depressive disorder Each subject will participate in this study up to 98 days up to 28 days for screening 42 days for double-blind treatment and a 4-week follow-up period Subjects will return to the clinic one time each week to have the severity of their depression assessed using the Hamilton depression rating scale-17 Adverse events that occurred since the last study visit will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None