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Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder - 3 Month Extension Study

NCT05438758 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-11-15

No results posted yet for this study

Summary

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)

Conditions

  • Treatment Resistant Major Depressive Disorder

Interventions

BEHAVIORAL

Almond Therapy

Participants will receive 12 remote session conducted by video or phone. Therapy sessions consist of modules selected using a shared decision making process, tailored so that it is personally meaningful to each participants. Participants will also receive supportive text messages on selective days over the 3 months.

DRUG

Intranasal ketamine (Esketamine)

Participants will receive 56 mg or 84 mg once a week for 4 weeks followed by 56 mg or 84 mg once every two weeks for 8 weeks

BEHAVIORAL

Treatment as Usual

Participants will continue to received 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 activity or relaxation.

Sponsors & Collaborators

  • Zylorion Health

    lead INDUSTRY

Principal Investigators

  • Pierre Chue, MBBCh · Amygdala Associates Inc.

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
2023-01-15
Primary Completion
2024-02-01
Completion
2024-03-01

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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 NCT05438758 on ClinicalTrials.gov