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

NCT ID: NCT05438758

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-03-01

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)

Detailed Description

The duration of the study is 3 months

Participants enrolled in the Almond Therapy group will have up to 9 in person visits, including the baseline visits, participants will receive Esketamine on 8 of these visits. There are 12 remote therapy sessions conducted via telephone or video, participants will also receive supportive text messages. In addition, participants will have 4 telephone calls from an independent assessor to ask questions about their mental health (MADRS).

Participants enrolled in the Treatment as Usual group will have up to 9 in person visits, including the baseline visits, participants will receive Esketamine on 8 of these visits. Participants will continue to receive the therapy their treating physician felt was appropriate at the time of enrolment in the study. In addition, participants will have 4 telephone calls from an independent assessor to ask questions about their mental health (MADRS).

Participants will receive intranasal Esketamine 56mg or 84 mg once weekly for 4 weeks and 56 mg or 84 mg once every 2 weeks for 8 weeks as per Product Monograph

Conditions

Treatment Resistant Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intranasal Esketamine with Addition of Almond TherapyTM

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.

Group Type: OTHER

Almond Therapy

Intervention Type: 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 ketamine (Esketamine)

Intervention Type: 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 Treatment as Usual

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.

Group Type: OTHER

Intranasal ketamine (Esketamine)

Intervention Type: 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

Treatment as Usual

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Participants must have completed Study ZYL-730-01 through to Day 28

2. Adults aged 18-64

3. 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.

4. 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.

5. If currently receiving medication for depression their antidepressant dose(s) must be stable for the previous 4 weeks prior to baseline.

6. 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.)

7. Controlled hypertension and must be on a stable dose of antihypertensive medications for at least 3 months prior to the baseline visit.

Exclusion Criteria

1. Women who plan to become pregnant, are pregnant or are breastfeeding.

2. Serious unstable medical illness, or any significant change in medical status at the baseline visit and during the study, as determined by the Investigator

3. Hormonal treatment (e.g., Estrogen) started within the 3 months prior to first dose of study treatment.

4. 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 .

5. 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

6. 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

7. 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.

8. Participants currently taking St John's Wort, Ginseng or Turmeric who start any of these during the study

9. 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.

10. Blood pressure >140/90 at baseline

11. Participants who are unable to easily travel to the clinic for all of the in-person visits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zylorion Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Chue, MBBCh

Role: PRINCIPAL_INVESTIGATOR

Amygdala Associates Inc.

Other Identifiers

HREBA-CTC-22-0066

Identifier Type: -

Identifier Source: org_study_id