NCT05323019

Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Zylorion Health · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The duration of the study is 28 days. Participants enrolled in the Almond Therapy arm will have up 10 in person clinic visits, including the screening visit, participants will receive esketamine on 8 of these visits. There are also 8 remote therapy sessions conducted via telephone or video, and participants will also receive supportive text messages. Participants will have 5 telephone calls from an independent assessor to ask questions about their mental health (MADRS). Participants enrolled in the Treatment as usual will have 10 in-person clinic visits, including the Screening visit, participants will receive intranasal esketamine on 8 of these visits. Participants will continue to receive the therapy that their treating physician felt was appropriate at the time of enrolment in the study. In addition, participants will have 5 telephone calls from an independent assessor to ask questions on their mental health ( MADRS). Participants will receive intranasal esketamine twice-weekly according to the Product Monograph. To ensure that both groups receive approximately equal amounts of esketamine, patients will receive 56mg initially for a maximum of 2 weeks followed by 56mg or 84mg. As per the Product Monograph these will be given for 4 weeks for a total of 8 doses during the 28-day study.

Conditions

• Treatment Resistant Major Depressive Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Psychotherapy	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.
BEHAVIORAL	Treatment as Usual	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.
DRUG	Intranasal Ketamine (esketamine)	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

Timeline

• Start date: 2022-10-13
• Primary completion: 2023-02-01
• Completion: 2023-02-01
• First posted: 2022-04-12
• Last updated: 2023-03-24

Locations

1 site across 1 country: Canada