Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524830
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Study to Assess the Efficacy Safety and Tolerability of VLS-01 Buccal Film Compared to Placebo in Patients With Treatment Resistant Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Multicenter Double-blind Randomized Placebo-controlled Trial to Assess the Efficacy Safety and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants With Treatment Resistant Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
This Phase 2 study protocol number VLS-01-203 will determine the efficacy safety and tolerability of short-term VLS-01-BU treatment in patients with TRD and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo
Detailed Description:
This Phase 2 multicenter double-blind randomized placebo-controlled trial will enroll approximately 142 participants with TRD randomized 11 to receive a total of 2 double-blind administrations of VLS-01-BU buccal film containing NN dimethyltryptamine DMT or placebo administered via the buccal transmucosal route with a 2-week interval between each administration during the placebo-controlled treatment period All participants will have their symptoms monitored for 12 weeks in the placebo-controlled follow-up period following the second administration of VLS-01-BU or placebo All participants will then be re-randomized 11 to receive one double-blinded administration of VLS-01-BU dose strength 1 or dose strength 2 during the non-placebo-controlled treatment period Final safety and efficacy assessment will be conducted two weeks after administration of the third dose
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