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

NCT05438758 | Withdrawn Phase 2

• 1 other identifier: HREBA-CTC-22-0066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery Asberg Depression Rating Scale (MADRS)

  The MADRS is a clinician rated 10-item scale where individuals score from 0-6 based on the severity of their symptoms with higher scores indicative of greater severity

  Baseline, Day 26, 54 and 89

Secondary Outcomes (5)

• Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5

  Baseline, Day 26, 54 and 82

• Change in Patient Health Questionnaire (PHQ-9)

  Baseline, Day 12, 26, 40, 54, 68 and 82

• Change in Generalized Anxiety Disorder Questionnaire (GAD-7)

  Baseline, Day 12, 26, 40, 54, 68 and 82

• Change in Rosenberg Self-Esteem Questionnaire (RSES)

  Baseline, Day 26, 54 and 82

• Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)

  Baseline, Day 26, 54 and 82

Study Arms (2)

Intranasal Esketamine with Addition of Almond TherapyTM

OTHER

Intranasal Esketamine - Dose of 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: Almond Therapy; Drug: Intranasal ketamine (Esketamine)

Intranasal Esketamine with Treatment as Usual

OTHER

Intranasal Esketamine - Dose of 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.

Drug: Intranasal ketamine (Esketamine); Behavioral: Treatment as Usual

Interventions

Almond Therapy BEHAVIORAL

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.

Intranasal Esketamine with Addition of Almond TherapyTM

Intranasal ketamine (Esketamine) DRUG

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

Intranasal Esketamine with Addition of Almond TherapyTM; Intranasal Esketamine with Treatment as Usual

Treatment as Usual BEHAVIORAL

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.

Intranasal Esketamine with Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must have completed Study ZYL-730-01 through to Day 28
• Adults aged 18-64
• Participants must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent.
• Women must use a medically acceptable reliable means of contraception and must agree to use adequate birth control for the duration of the study and for 6 weeks after the last dose using methods from the permitted list for contraception.
• If currently receiving medication for depression their antidepressant dose(s) must be stable for the previous 4 weeks prior to baseline.
• Must be on a stable dose of all other medication(s) for at least 1-month prior to baseline visit., unless medication is to treat other short term conditions (i.e. influenza, upper respiratory track infections, pain, etc.)
• Controlled hypertension and must be on a stable dose of antihypertensive medications for at least 3 months prior to the baseline visit.

You may not qualify if:

• Women who plan to become pregnant, are pregnant or are breastfeeding.
• Serious unstable medical illness, or any significant change in medical status at the baseline visit and during the study, as determined by the Investigator
• Hormonal treatment (e.g., Estrogen) started within the 3 months prior to first dose of study treatment.
• Participants who report treatment with a benzodiazepine, an opioid medication, or a mood stabilizer (such as valproic acid or lithium) at the baseline visit and within 2 weeks prior to the first dose of Esketamine .
• Participants with confirmed psychotic disorder or symptoms, bipolar disorder and or clinically significant alcohol or substance misuse confirmed by a psychiatrist at the baseline visit. Those participants who develop symptoms of these may be withdrawn from the study, as determined by the Investigator
• Current diagnosis of bulimia nervosa, or development of significant eating disorder symptoms at the baseline visit or during the study as determined by the Investigator
• Participants who have been diagnosed with ADD/ADHD and who are also currently taking stimulant medication such as methylphenidate or another amphetamine-type medication, or who are diagnosed with this disorder or who start medication for this during the study.
• Participants currently taking St John's Wort, Ginseng or Turmeric who start any of these during the study
• Participants judged clinically to be actively at serious risk of self-harm or suicidal behaviour by the study team or psychiatrist at baseline or at any time during the study, as determined by the Investigator.
• Blood pressure \>140/90 at baseline
• Participants who are unable to easily travel to the clinic for all of the in-person visits.

Sponsors & Collaborators

• Zylorion Health: lead

MeSH Terms

Interventions

Esketamine; Therapeutics

Study Officials

• Pierre Chue, MBBCh

  Amygdala Associates Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent trained individual will not be aware of which treatment arm the participant is in. The Montgomery Asberg Depression Rating Scale (MADRS) assessor will have no other contact with participant apart from remotely assessing the MADRS
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants who have received Almond Therapy in study ZYL-730-01 will continue to have this in the extension study Participants who received Treatment as Usual in study ZYL-730-02 will continue to have this in the extension study.

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 30, 2022
• Study Start: January 15, 2023
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Throughout the study
• Access Criteria: Involved in data collection