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Treatment Resistant Major Depressive DisorderPhase 2ZYL-730-02NCT05438758

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

A Phase 2 study testing Almond Therapy, Intranasal ketamine (Esketamine) and Treatment as Usual in people with Treatment Resistant Major Depressive Disorder, run by Zylorion Health.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
Almond Therapy, Intranasal ketamine (Esketamine) and Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jan 2023to 1 Mar 2024
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

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

About this study

Official title: Phase 2, Controlled, Single-Blind, 3-Month Extension Study For Participants Originally Diagnosed With Treatment Resistant Major Depressive Disorder (TRD) Who Complete Study ZYL-730-01 With, or Without, Almond Therapy

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)

Read the 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

Being tested
Almond Therapy, Intranasal ketamine (Esketamine), Treatment as Usual

What participants receive

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

  • Almond TherapyBehavioural

    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)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 UsualBehavioural

    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.

Study groups in NCT05438758
Study groupRoleWhat they receive
Intranasal Esketamine with Addition of Almond TherapyTMOtherIntranasal 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.
Receives: Behavioral: Almond Therapy; Drug: Intranasal ketamine (Esketamine)
Intranasal Esketamine with Treatment as UsualOtherIntranasal 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.
Receives: Drug: Intranasal ketamine (Esketamine); Behavioral: Treatment as Usual

What is being measured

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

  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

    Measured: Baseline, Day 26, 54 and 89

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 derived from the symptoms of PTSD in DSM-5. Participants will be asked to rate how bothered they have been by each item in the 4 weeks 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: Baseline, Day 26, 54 and 82

  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 everyday

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

  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 scored 0-3, giving a total score of 0-21.

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

  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 indication greater self-esteem

    Measured: Baseline, Day 26, 54 and 82

  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: Baseline, Day 26, 54 and 82

Timeline

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

  1. First posted30 Jun 2022
  2. Study start15 Jan 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Why it stopped: Withdrawn by Sponsor

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 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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438758
Sponsor's protocol ID
HREBA-CTC-22-0066
Acronym
ZYL-730-02
Status last verified
Nov 2022
First submitted
24 Jun 2022
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will be available to other members of the study team including Dr. Craig Buchholz

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Almond Therapy, Intranasal ketamine (Esketamine) and Treatment as Usual in people with Treatment Resistant Major Depressive Disorder, run by Zylorion Health.

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 11 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: withdrawn, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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 Montgomery Asberg Depression Rating Scale (MADRS) (time frame: Baseline, Day 26, 54 and 89). 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 NCT05438758.

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 15 Nov 2022.

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