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Treatment Resistant Major Depressive DisorderPhase 2ZYL-730-01NCT05323019

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

A Phase 2 study testing Psychotherapy, Treatment as Usual and Intranasal Ketamine (esketamine) in people with Treatment Resistant Major Depressive Disorder, run by Zylorion Health at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 64 years
What is being tested?
Psychotherapy, Treatment as Usual and Intranasal Ketamine (esketamine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteCanada
Study dates
13 Oct 2022to 1 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • City Center Pharmacy and Medical Clinic

    Edmonton, Alberta, T5J 5C2

Other trials in Canada

About this study

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

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

Read the 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.

Being tested
Psychotherapy, Treatment as Usual, Intranasal Ketamine (esketamine)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PsychotherapyBehavioural

    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.

  • Treatment as UsualBehavioural

    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.

  • Intranasal Ketamine (esketamine)Drug

    Also called Spravato

    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

Study groups in NCT05323019
Study groupRoleWhat they receive
Intranasal (esketamine) Ketamine with Addition of Almond therapyOtherIntranasal (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.
Receives: Behavioral: Psychotherapy; Drug: Intranasal Ketamine (esketamine)
Intranasal (esketamine) Ketamine with Treatment as UsualOtherIntranasal (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.
Receives: Behavioral: Treatment as Usual; Drug: Intranasal Ketamine (esketamine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Screening, Day 7, 14, 21 and 28

Secondary outcomes (5)

  1. 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

    Measured: Screening and Day 28

  2. 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).

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

  3. 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.

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

  4. 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

    Measured: Screening and Day 28

  5. 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.

    Measured: Screening and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2022
  2. Study start13 Oct 2022
  3. Primary completion1 Feb 2023
  4. Study completion1 Feb 2023

Why it stopped: Funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized by a pre-specified block design method after confirming eligibility.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05323019
Sponsor's protocol ID
HREBA-CTC-22-0015
Acronym
ZYL-730-01
Status last verified
Mar 2023
First submitted
24 Mar 2022
Last updated
24 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available to other members of the research team including Dr. Craig Buchholz

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Psychotherapy, Treatment as Usual and Intranasal Ketamine (esketamine) in people with Treatment Resistant Major Depressive Disorder, run by Zylorion Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28 (time frame: Screening, Day 7, 14, 21 and 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05323019.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.

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