Clinical TrialTreatment-Resistant Depression (TRD)EsketamineEsketamineWithdrawn

Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder – 3 Month Extension Study (ZYL-730-02)

Single-blind, randomised, parallel extension (withdrawn) assessing maintenance of improvement over 3 months (n=0) with intranasal esketamine (56 or 84 mg, 8 doses) plus Almond Therapy versus esketamine plus treatment as usual in participants with TRD.

Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized, single Blind

Detailed Description

This 3-month extension randomised study compares intranasal esketamine (56 or 84 mg according to Product Monograph; 8 administrations over 3 months) plus Almond Therapy versus esketamine plus treatment as usual in participants previously enrolled in ZYL-730-01.

Almond Therapy comprises up to 12 remote sessions tailored to participants plus supportive text messages; participants also receive up to 9 in-person visits and remote MADRS assessments by an independent assessor.

Study Protocol

Preparation

sessions

Dosing

8 sessions

Integration

12 sessions

Therapeutic Protocol

support

Study Arms & Interventions

Esketamine + Almond Therapy

experimental

Intranasal esketamine (56 or 84 mg) plus Almond Therapy (12 remote sessions) with up to 9 in-person visits; 8 esketamine administrations over 3 months.

Interventions

  • Esketamine56 - 84 mg
    via Other• weekly then biweekly• 8 doses total

    Intranasal (56 or 84 mg) per Product Monograph; 8 doses over 3 months

  • Compound
    via Other• 12 sessions

    Almond Therapy: 12 remote sessions by video/phone; supportive text messages

Esketamine + TAU

active comparator

Intranasal esketamine (56 or 84 mg) plus Treatment as Usual behavioural support; up to 9 in-person visits; 8 esketamine administrations over 3 months.

Interventions

  • Esketamine56 - 84 mg
    via Other• weekly then biweekly• 8 doses total

    Intranasal (56 or 84 mg) per Product Monograph; 8 doses over 3 months

  • Compound
    via Other• variable

    Treatment as Usual behavioural support (CBT, supportive psychotherapy, mindfulness, support groups, or other as arranged by treating physician)

Participants

Ages
18 – 64
Sexes
Male & Female

Inclusion 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

  • 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.

Study Details

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