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

Z

Zylorion Health

Status and phase

Withdrawn
Phase 2

Conditions

Treatment Resistant Major Depressive Disorder

Treatments

Behavioral: Almond Therapy
Drug: Intranasal ketamine (Esketamine)
Behavioral: Treatment as Usual

Study type

Interventional

Funder types

Industry

Identifiers

NCT05438758
HREBA-CTC-22-0066

Details and patient eligibility

About

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)

Full 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

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Intranasal Esketamine with Addition of Almond TherapyTM
Other group
Description:
Intranasal 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.
Treatment:
Drug: Intranasal ketamine (Esketamine)
Behavioral: Almond Therapy
Intranasal Esketamine with Treatment as Usual
Other group
Description:
Intranasal 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.
Treatment:
Behavioral: Treatment as Usual
Drug: Intranasal ketamine (Esketamine)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems