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Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression (ZYL-730-01)

Primary Purpose

Treatment Resistant Major Depressive Disorder

Status

Terminated

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Psychotherapy

Treatment as Usual

Intranasal Ketamine (esketamine)

About this trial

This is an interventional treatment trial for Treatment Resistant Major Depressive Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Score on MADRS scale with a score of 18 or greater
Meet criteria for Treatment-Resistant Major Depressive Disorder, defined as having not responded adequately to at least two separate courses of treatment with different antidepressant at an adequate dose and duration in the current moderate to severe depression episode, as determined by an appropriately trained psychiatrist.
Women of child bearing potential must use a medically acceptable means of contraception for the duration of the study and for 6 weeks after the last dose of esktamine.
Negative blood pregnancy test prior to baseline
If currently receiving medication for depression, antidepressant dose must be stable for the previous 4 weeks prior to baseline.
Stable dose of all other medication for at least 1 month prior to baseline
Controlled hypertension and on a stable dose of antihypertension medications for at least 3 months prior to baseline visit

Exclusion Criteria:

Women who plan to become pregnant, are pregnant or are breastfeeding
Serious unstable medical illness as determined by the Investigator.
Participants with uncontrolled hypothyroidism and hyperthyroidism
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) 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 in the previous 2 years.
Previous ketamine abuse as determined by Investigator
Previous non-response to clinical or research ketamine administration
Current diagnosis of bulimia nervosa
Participants who have been diagnosed with ADD/ADHD and who are also currently taking stimulant medication such as methylphenidate or another amphetamine-type medication.
Participants currently taking St John's Wort, Ginseng or Turmeric
Participants judged clinically to be actively at serious risk of self-harm or suicidal behaviour by the study team or psychiatrist at Screening.
Blood pressure >140/90 at screening

Sites / Locations

City Center Pharmacy and Medical Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Intranasal (esketamine) Ketamine with Addition of Almond therapy

Intranasal (esketamine) Ketamine with Treatment as Usual

Arm Description

Intranasal (esketamine) Ketamine - Dose of 56mg for a maximum of 2 weeks, followed by 56 mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Intranasal (esketamine) Ketamine - Dose of 56 mg for a maximum of 2 weeks, followed by 56mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Outcomes

Primary Outcome Measures

Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28

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

Secondary Outcome Measures

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

A 20-item self-administered measure that assesses the presence and severity of PTSD symptoms. Participants will be asked to rate how bothered they have been by each itme in the past month on a 5-point Likert scale ranging from 0=Not at all to 4 = Extremely. The PCL-5 is easily scored by summing all of the items for a total symptom severity score ranging between 0-80. Clinically meaningful PTSD symptoms are present if items are rated as a minimum of 2 = "Moderate" or higher

Change in Patient Health Questionnaire (PHQ-9)

A 9-item self-administered questionnaire to determine the presence and severity of depression which scores each of the 9 DSM-IV criteria as "0" ( not at all), to "3" ( nearly every day).

Change in Generalized Anxiety Disorder Questionnaire (GAD-7)

A 7- item self-administered questionnaire to measure the severity of the levels of anxiety. Each item can be score 0-3, giving a total score of 0-21.

Change in Rosenberg Self-Esteem Questionnaire (RSES)

A 10-item self-administered questionnaire to measure change in self esteem following psychological intervention. Each item scoring from 1-4, and higher scores indicating greater self-esteem

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

Self administered questionnaire measuring quality of life across 8 domains: independent living, happiness, mental health, coping, relationships, self-worth, pain and senses.

Full Information

NCT ID

NCT05323019

First Posted

March 24, 2022

Last Updated

March 22, 2023

Sponsor

Zylorion Health

1. Study Identification

Unique Protocol Identification Number

NCT05323019

Brief Title

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

Acronym

ZYL-730-01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Terminated

Why Stopped

Funding

Study Start Date

October 13, 2022 (Actual)

Primary Completion Date

February 1, 2023 (Actual)

Study Completion Date

February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zylorion Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment Resistant Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Participants will be randomized by a pre-specified block design method after confirming eligibility.

Masking

Outcomes Assessor

Masking Description

The independent trained individual will not be aware of which treatment arm the participant has been randomized to. The MADRS assessor will have no other contact with the participants apart from remotely assessing the MADRS

Allocation

Randomized

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal (esketamine) Ketamine with Addition of Almond therapy

Arm Type

Other

Arm Description

Intranasal (esketamine) Ketamine - Dose of 56mg for a maximum of 2 weeks, followed by 56 mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Arm Title

Intranasal (esketamine) Ketamine with Treatment as Usual

Arm Type

Other

Arm Description

Intranasal (esketamine) Ketamine - Dose of 56 mg for a maximum of 2 weeks, followed by 56mg or 84mg twice a week for a total of 8 doses during the 28 day study.

Intervention Type

Behavioral

Intervention Name(s)

Psychotherapy

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Treatment as Usual

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intranasal Ketamine (esketamine)

Other Intervention Name(s)

Spravato

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28

Description

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

Time Frame

Screening, Day 7, 14, 21 and 28

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Screening and Day 28

Title

Change in Patient Health Questionnaire (PHQ-9)

Description

A 9-item self-administered questionnaire to determine the presence and severity of depression which scores each of the 9 DSM-IV criteria as "0" ( not at all), to "3" ( nearly every day).

Time Frame

Screening, Day 2, 5, 9, 12,16, ,19, 23, 26 and 28

Title

Change in Generalized Anxiety Disorder Questionnaire (GAD-7)

Description

A 7- item self-administered questionnaire to measure the severity of the levels of anxiety. Each item can be score 0-3, giving a total score of 0-21.

Time Frame

Screening, Day 2, 5, 9, 12, 16, 19, 23, 26 and 28

Title

Change in Rosenberg Self-Esteem Questionnaire (RSES)

Description

A 10-item self-administered questionnaire to measure change in self esteem following psychological intervention. Each item scoring from 1-4, and higher scores indicating greater self-esteem

Time Frame

Screening and Day 28

Title

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

Description

Self administered questionnaire measuring quality of life across 8 domains: independent living, happiness, mental health, coping, relationships, self-worth, pain and senses.

Time Frame

Screening and Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Score on MADRS scale with a score of 18 or greater Meet criteria for Treatment-Resistant Major Depressive Disorder, defined as having not responded adequately to at least two separate courses of treatment with different antidepressant at an adequate dose and duration in the current moderate to severe depression episode, as determined by an appropriately trained psychiatrist. Women of child bearing potential must use a medically acceptable means of contraception for the duration of the study and for 6 weeks after the last dose of esktamine. Negative blood pregnancy test prior to baseline If currently receiving medication for depression, antidepressant dose must be stable for the previous 4 weeks prior to baseline. Stable dose of all other medication for at least 1 month prior to baseline Controlled hypertension and on a stable dose of antihypertension medications for at least 3 months prior to baseline visit Exclusion Criteria: Women who plan to become pregnant, are pregnant or are breastfeeding Serious unstable medical illness as determined by the Investigator. Participants with uncontrolled hypothyroidism and hyperthyroidism 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) 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 in the previous 2 years. Previous ketamine abuse as determined by Investigator Previous non-response to clinical or research ketamine administration Current diagnosis of bulimia nervosa Participants who have been diagnosed with ADD/ADHD and who are also currently taking stimulant medication such as methylphenidate or another amphetamine-type medication. Participants currently taking St John's Wort, Ginseng or Turmeric Participants judged clinically to be actively at serious risk of self-harm or suicidal behaviour by the study team or psychiatrist at Screening. Blood pressure >140/90 at screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre Chue, MBBCh

Organizational Affiliation

Amygdala Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

City Center Pharmacy and Medical Clinic

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5J 5C2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

IPD will be available to other members of the research team including Dr. Craig Buchholz

IPD Sharing Time Frame

Throughout the study.

IPD Sharing Access Criteria

Involved in data collection

Learn more about this trial

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

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