This single-blind, controlled, 3-month extension study (n=0, withdrawn) for participants originally diagnosed with treatment-resistant major depressive disorder (TRD) aimed to assess if improvements in depressive symptoms were maintained over the medium and longer term, up to 3 months.
Sponsored by Zylorion Health, the study had an estimated start date of January 2023 and was anticipated to conclude by March 2024. However, it was withdrawn before any participants were enrolled.
The study design involved participants who completed Study ZYL-730-01 continuing to receive Almond Therapy or Treatment as Usual in the extension study. Those receiving Almond Therapy would undergo intranasal Esketamine treatment alongside 12 remote therapy sessions tailored to individual needs, supplemented with supportive text messages over the 3-month period. Participants in the Treatment as Usual group would receive Esketamine treatment and continue therapy prescribed by their treating physician, with similar remote assessments.
Primary outcome measures included changes in the Montgomery Asberg Depression Rating Scale (MADRS) at various time points, while secondary outcome measures included assessments of PTSD symptoms, depression severity, anxiety levels, self-esteem, and quality of life.
Eligibility criteria specified that participants must have completed the previous study, be aged 18-64, have a stable antidepressant regimen, and meet other health criteria. Exclusion criteria included pregnancy, unstable medical conditions, recent medication changes, and certain psychiatric disorders or risk factors.
Although the study was planned to assess the effectiveness of intranasal Esketamine alongside Almond Therapy or Treatment as Usual, it was withdrawn before enrolment, and no results were available.
Trial Details
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)Trial Number NCT05438758