Withdrawn by Sponsor
ZYL-730-02
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
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2022
Actual (reported)June 30, 2022
Actual (reported)January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in Montgomery Asberg Depression Rating Scale (MADRS)
The MADRS is a clinician rated 10-item scale where individuals score from 0-6 based on the severity of their symptoms with higher scores indicative of greater severity
Baseline, Day 26, 54 and 89
Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5
Baseline, Day 26, 54 and 82
Change in Patient Health Questionnaire (PHQ-9)
Baseline, Day 12, 26, 40, 54, 68 and 82
Change in Generalized Anxiety Disorder Questionnaire (GAD-7)
Baseline, Day 12, 26, 40, 54, 68 and 82
Change in Rosenberg Self-Esteem Questionnaire (RSES)
Baseline, Day 26, 54 and 82
Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)
Baseline, Day 26, 54 and 82
Intranasal Esketamine - Dose of 56 mg or 84 mg once a week for 4 weeks followed by 56 mg or 84 mg once every two weeks for 8 weeks.
Intranasal Esketamine - Dose of 56 mg or 84 mg once a week for 4 weeks followed by 56 mg or 84 mg once every two weeks for 8 weeks.
Participants will receive 12 remote session conducted by video or phone. Therapy sessions consist of modules selected using a shared decision making process, tailored so that it is personally meaningful to each participants. Participants will also receive supportive text messages on selective days over the 3 months.
Participants will receive 56 mg or 84 mg once a week for 4 weeks followed by 56 mg or 84 mg once every two weeks for 8 weeks
Pierre Chue, MBBCh
Amygdala Associates Inc.
0 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2022
First Posted
June 30, 2022
Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD
Participants will continue to received the therapy that their treating physician felt was appropriate at the time of enrolment in the study. These can include cognitive behavioural therapy, supportive psychotherapy or mindfulness, support groups, physical activity or relaxation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
January 15, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 15, 2022
Record last verified: 2022-11
IPD will be available to other members of the study team including Dr. Craig Buchholz
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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