Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05438758
Status:
WITHDRAWN
Last Update Posted:
2022-11-15
First Post:
2022-06-24
Brief Title:
Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study
Sponsor:
Zylorion Health
Organization:
Zylorion Health
Study Overview
Official Title:
Phase 2 Controlled Single-Blind 3-Month Extension Study For Participants Originally Diagnosed With Treatment Resistant Major Depressive Disorder TRD Who Complete Study ZYL-730-01 With or Without Almond Therapy
Status:
WITHDRAWN
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZYL-730-02
Brief Summary:
The purpose of this study is to determine if any improvements in depressive symptoms are maintained in the medium and longer-term up to 3 months
Detailed Description:
The duration of the study is 3 months
Participants enrolled in the Almond Therapy group will have up to 9 in person visits including the baseline visits participants will receive Esketamine on 8 of these visits There are 12 remote therapy sessions conducted via telephone or video participants will also receive supportive text messages In addition participants will have 4 telephone calls from an independent assessor to ask questions about their mental health MADRS
Participants enrolled in the Treatment as Usual group will have up to 9 in person visits including the baseline visits participants will receive Esketamine on 8 of these visits Participants will continue to receive the therapy their treating physician felt was appropriate at the time of enrolment in the study In addition participants will have 4 telephone calls from an independent assessor to ask questions about their mental health MADRS
Participants will receive intranasal Esketamine 56mg or 84 mg once weekly for 4 weeks and 56 mg or 84 mg once every 2 weeks for 8 weeks as per Product Monograph
Participants enrolled in the Almond Therapy group will have up to 9 in person visits including the baseline visits participants will receive Esketamine on 8 of these visits There are 12 remote therapy sessions conducted via telephone or video participants will also receive supportive text messages In addition participants will have 4 telephone calls from an independent assessor to ask questions about their mental health MADRS
Participants enrolled in the Treatment as Usual group will have up to 9 in person visits including the baseline visits participants will receive Esketamine on 8 of these visits Participants will continue to receive the therapy their treating physician felt was appropriate at the time of enrolment in the study In addition participants will have 4 telephone calls from an independent assessor to ask questions about their mental health MADRS
Participants will receive intranasal Esketamine 56mg or 84 mg once weekly for 4 weeks and 56 mg or 84 mg once every 2 weeks for 8 weeks as per Product Monograph
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None