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
Overview
- Phase
- Phase 2
- Intervention
- Almond Therapy
- Conditions
- Treatment Resistant Major Depressive Disorder
- Sponsor
- Zylorion Health
- Primary Endpoint
- Change in Montgomery Asberg Depression Rating Scale (MADRS)
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief 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)
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Intranasal Esketamine with Addition of Almond TherapyTM
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.
Intervention: Almond Therapy
Intranasal Esketamine with Addition of Almond TherapyTM
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.
Intervention: Intranasal ketamine (Esketamine)
Intranasal Esketamine with Treatment as Usual
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.
Intervention: Intranasal ketamine (Esketamine)
Intranasal Esketamine with Treatment as Usual
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.
Intervention: Treatment as Usual
Outcomes
Primary Outcomes
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: Baseline, Day 26, 54 and 89
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
Secondary Outcomes
- Change in Rosenberg Self-Esteem Questionnaire (RSES)(Baseline, Day 26, 54 and 82)
- Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)(Baseline, Day 26, 54 and 82)
- Change in Post-Traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5(Baseline, Day 26, 54 and 82)
- Change in Patient Health Questionnaire (PHQ-9)(Baseline, Day 12, 26, 40, 54, 68 and 82)
- Change in Generalized Anxiety Disorder Questionnaire (GAD-7)(Baseline, Day 12, 26, 40, 54, 68 and 82)