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

NCT05323019 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-03-24

No results posted yet for this study

Summary

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

Conditions

  • Treatment Resistant Major Depressive Disorder

Interventions

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

Sponsors & Collaborators

  • Zylorion Health

    lead INDUSTRY

Principal Investigators

  • Pierre Chue, MBBCh · Amygdala Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2023-02-01
Completion
2023-02-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05323019 on ClinicalTrials.gov