Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression (ZYL-730-01)

This single-blind, Phase II study (n=6; terminated) aimed to evaluate the efficacy of Almond Therapy™ in addition to intranasal esketamine (SpravatoTM) compared to Treatment as Usual over a 28-day period in patients with treatment-resistant major depressive disorder (TRMDD).

Sponsored by Zylorion Health, the study commenced on October 13, 2022, and ended on February 1, 2023, with an actual enrollment of 6 participants. Participants received intranasal esketamine twice-weekly for 4 weeks, with doses ranging from 56mg initially to 56mg or 84mg subsequently. The Almond Therapy™ arm included 8 remote therapy sessions and supportive text messages, while the Treatment as Usual arm continued therapy prescribed by their treating physician.

The primary outcome measure was the change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28. Secondary outcome measures included changes in PTSD symptoms, depression severity, anxiety levels, self-esteem, and quality of life. Participants had to meet specific inclusion criteria, including a MADRS score of 18 or higher and a diagnosis of TRMDD. Exclusion criteria comprised various factors such as pregnancy, serious medical illnesses, recent medication changes, and psychiatric disorders.

The study followed a randomized, controlled, single-blind design with parallel assignment. The independent assessor evaluating outcomes was masked to treatment allocation. Collaborators included Amygdala Associates, and there were no publications associated with the study as of the last update posted on March 24, 2023.

Topic Treatment-Resistant Depression Depression
Compound Ketamine
Country Canada
Visit trial
Status Terminated
Results Published No
Start date 13 October 2022
End date 01 February 2023
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 6
Sex All
Age 18- 64
Therapy Yes

Trial Details

To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.

NCT Number NCT05323019

Data attribution

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