Funding
ZYL-730-01
A Randomized, Controlled, Single-Blind, Phase 2 Study in Treatment Resistant Major Depressive Disorder Patients Receiving Intranasal Esketamine (SpravatoTM) Over a 28-day Period Comparing Addition of Almond TherapyTM With Treatment-as-Usual
Sponsor study identifier
interventional
6
1 country
1
Study Start
October 13, 2022
Actual (reported)Primary Completion
February 1, 2023
Actual (reported)Study Completion
February 1, 2023
Actual (reported)To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2023
Actual (reported)Click on a node to explore related trials.
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.
March 24, 2022
Actual (reported)April 12, 2022
Actual (reported)October 13, 2022
Actual (reported)February 1, 2023
Actual (reported)February 1, 2023
Actual (reported)Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28
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
Screening, Day 7, 14, 21 and 28
Change in Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)
Screening and Day 28
Change in Patient Health Questionnaire (PHQ-9)
Screening, Day 2, 5, 9, 12,16, ,19, 23, 26 and 28
Change in Generalized Anxiety Disorder Questionnaire (GAD-7)
Screening, Day 2, 5, 9, 12, 16, 19, 23, 26 and 28
Change in Rosenberg Self-Esteem Questionnaire (RSES)
Screening and Day 28
Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)
Screening and Day 28
Intranasal (esketamine) Ketamine - Dose of 56mg for a maximum of 2 weeks, followed by 56 mg or 84mg twice a week for a total of 8 doses during the 28 day study.
Intranasal (esketamine) Ketamine - Dose of 56 mg for a maximum of 2 weeks, followed by 56mg or 84mg twice a week for a total of 8 doses during the 28 day study.
Participants will receive 8 remote therapy sessions conducted via phone or video, Therapy sessions consists of modules selected using a shared decision making process, tailored so that it is personally meaningful to each participant. Participants will also receive supportive text messages on selected days during the 28 day study.
Participants will continue to receive 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 exercise or relaxation.
City Center Pharmacy and Medical Clinic
Edmonton, Alberta, T5J 5C2, Canada
Pierre Chue, MBBCh
Amygdala Associates
6 participants (actual enrollment reported by the registry).
First Submitted
March 24, 2022
First Posted
April 12, 2022
Intranasal Ketamine (esketamine) - participants will receive a dose of 56 mg for a maximum of 2 weeks, followed by 56 mg or 84 twice a week for a total of 8 doses during the 28 -day study
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
October 13, 2022
Actual (reported)Primary Completion
February 1, 2023
Actual (reported)Study Completion
February 1, 2023
Actual (reported)Last Updated
March 24, 2023
Record last verified: 2023-03
IPD will be available to other members of the research 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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