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WithdrawnPhase 2

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

NCT05438758 · ZYL-730-02 · Zylorion Health

Closed to entry
Status
Not accepting participants
Phase 2
Phase
Target enrolment
Study sites

What it is testing

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)

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Montgomery Asberg Depression Rating Scale (MADRS)

    Measured over Baseline, Day 26, 54 and 89

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 64 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05438758 on ClinicalTrials.gov →

Last updated in the registry 2022-11-15. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits