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Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression (ZYL-730-01)

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ClinicalTrials.gov Identifier: NCT05323019
Recruitment Status : Not yet recruiting
First Posted : April 12, 2022
Last Update Posted : May 26, 2022
Sponsor:
Information provided by (Responsible Party):
Zylorion Health

Tracking Information
First Submitted Date  ICMJE March 24, 2022
First Posted Date  ICMJE April 12, 2022
Last Update Posted Date May 26, 2022
Estimated Study Start Date  ICMJE June 2022
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2022)
Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 28 [ Time Frame: Screening, Day 7, 14, 21 and 28 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2022)
  • Change in Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) [ Time Frame: Screening and Day 28 ]
    A 20-item self-administered measure that assesses the presence and severity of PTSD symptoms. Participants will be asked to rate how bothered they have been by each itme in the past month 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
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, Day 2, 5, 9, 12,16, ,19, 23, 26 and 28 ]
    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 every day).
  • Change in Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: Screening, Day 2, 5, 9, 12, 16, 19, 23, 26 and 28 ]
    A 7- item self-administered questionnaire to measure the severity of the levels of anxiety. Each item can be score 0-3, giving a total score of 0-21.
  • Change in Rosenberg Self-Esteem Questionnaire (RSES) [ Time Frame: Screening and Day 28 ]
    A 10-item self-administered questionnaire to measure change in self esteem following psychological intervention. Each item scoring from 1-4, and higher scores indicating greater self-esteem
  • Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D) [ Time Frame: Screening and Day 28 ]
    Self administered questionnaire measuring quality of life across 8 domains: independent living, happiness, mental health, coping, relationships, self-worth, pain and senses.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2022)
  • Change in Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) [ Time Frame: Screening and Day 28 ]
    A 20-item self-administered measure that assesses the presence and severity of PTSD symptoms. Participants will be asked to rate how bothered they have been by each itme in the past month 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
  • Change in Patient Health Questionnaire (PHQ-9) [ Time Frame: Screening, Day 2, 5, 9, 12,16, ,19, 23, 26 and 28 ]
    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 every day).
  • Change in Generalized Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: Screening, Day 2, 5, 9, 12, 16, 19, 23, 26 and 28 ]
    A 7- item self-administered questionnaire to measure the severity of the levels of anxiety. Each item can be score 0-3, giving a total score of 0-21.
  • Change in Rosenberg Self-Esteem Questionnaire (RSES) [ Time Frame: Screening and Day 28 ]
    A 10-item self-administered questionnaire to measure change in self esteem following psychological intervention. Each item scoring from 1-4, and higher scores indicating greater self-esteem
  • Change in EuroQol-5 Dimensional Questionnaire [ Time Frame: Screening and Day 28 ]
    Self administered questionnaire measuring quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Level 1 indicates best health and level 5 worst health. The Vertical Analogue Scale (VAS) records the participants self-rated health on a numbered scaled from 0-100, where 100 means "The best health imagined" and 0 means "The worst health you can imagine"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression
Official Title  ICMJE A Randomized, Controlled, Single-Blind, Phase 2 Study in Treatment Resistant Major Depressive Disorder Patients Receiving Intranasal Esketamine (SpravatoTM) Over a 28-day Period Comparing Addition of Almond TherapyTM With Treatment-as-Usual
Brief Summary To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.
Detailed Description

The duration of the study is 28 days.

Participants enrolled in the Almond Therapy arm will have up 10 in person clinic visits, including the screening visit, participants will receive esketamine on 8 of these visits. There are also 8 remote therapy sessions conducted via telephone or video, and participants will also receive supportive text messages. Participants will have 5 telephone calls from an independent assessor to ask questions about their mental health (MADRS).

Participants enrolled in the Treatment as usual will have 10 in-person clinic visits, including the Screening visit, participants will receive intranasal esketamine on 8 of these visits. Participants will continue to receive the therapy that their treating physician felt was appropriate at the time of enrolment in the study. In addition, participants will have 5 telephone calls from an independent assessor to ask questions on their mental health ( MADRS).

Participants will receive intranasal esketamine twice-weekly according to the Product Monograph. To ensure that both groups receive approximately equal amounts of esketamine, patients will receive 56mg initially for a maximum of 2 weeks followed by 56mg or 84mg. As per the Product Monograph these will be given for 4 weeks for a total of 8 doses during the 28-day study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized by a pre-specified block design method after confirming eligibility.
Masking: Single (Outcomes Assessor)
Masking Description:
The independent trained individual will not be aware of which treatment arm the participant has been randomized to. The MADRS assessor will have no other contact with the participants apart from remotely assessing the MADRS
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Major Depressive Disorder
Intervention  ICMJE
  • Behavioral: Psychotherapy
    Participants will receive 8 remote therapy sessions conducted via phone or video, Therapy sessions consists of modules selected using a shared decision making process, tailored so that it is personally meaningful to each participant. Participants will also receive supportive text messages on selected days during the 28 day study.
  • Behavioral: Treatment as Usual
    Participants will continue to receive 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 exercise or relaxation.
  • Drug: Intranasal Ketamine (esketamine)
    Intranasal Ketamine (esketamine) - participants will receive a dose of 56 mg for a maximum of 2 weeks, followed by 56 mg or 84 twice a week for a total of 8 doses during the 28 -day study
    Other Name: Spravato
Study Arms  ICMJE
  • Intranasal (esketamine) Ketamine with Addition of Almond therapy
    Intranasal (esketamine) Ketamine - Dose of 56mg for a maximum of 2 weeks, followed by 56 mg or 84mg twice a week for a total of 8 doses during the 28 day study.
    Interventions:
    • Behavioral: Psychotherapy
    • Drug: Intranasal Ketamine (esketamine)
  • Intranasal (esketamine) Ketamine with Treatment as Usual
    Intranasal (esketamine) Ketamine - Dose of 56 mg for a maximum of 2 weeks, followed by 56mg or 84mg twice a week for a total of 8 doses during the 28 day study.
    Interventions:
    • Behavioral: Treatment as Usual
    • Drug: Intranasal Ketamine (esketamine)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 4, 2022)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Score on MADRS scale with a score of 18 or greater
  • Meet criteria for Treatment-Resistant Major Depressive Disorder, defined as having not responded adequately to at least two separate courses of treatment with different antidepressant at an adequate dose and duration in the current moderate to severe depression episode, as determined by an appropriately trained psychiatrist.
  • Women of child bearing potential must use a medically acceptable means of contraception for the duration of the study and for 6 weeks after the last dose of esktamine.
  • Negative blood pregnancy test prior to baseline
  • If currently receiving medication for depression, antidepressant dose must be stable for the previous 4 weeks prior to baseline.
  • Stable dose of all other medication for at least 1 month prior to baseline
  • Controlled hypertension and on a stable dose of antihypertension medications for at least 3 months prior to baseline visit

Exclusion Criteria:

  • Women who plan to become pregnant, are pregnant or are breastfeeding
  • Serious unstable medical illness as determined by the Investigator.
  • Participants with uncontrolled hypothyroidism and hyperthyroidism
  • 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) 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 in the previous 2 years.
  • Previous ketamine abuse as determined by Investigator
  • Previous non-response to clinical or research ketamine administration
  • Current diagnosis of bulimia nervosa
  • Participants who have been diagnosed with ADD/ADHD and who are also currently taking stimulant medication such as methylphenidate or another amphetamine-type medication.
  • Participants currently taking St John's Wort, Ginseng or Turmeric
  • Participants judged clinically to be actively at serious risk of self-harm or suicidal behaviour by the study team or psychiatrist at Screening.
  • Blood pressure >140/90 at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lee-Ann Langkaas 780-257-8200 lee-ann.langkaas@zylorion.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05323019
Other Study ID Numbers  ICMJE HREBA-CTC-22-0015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: IPD will be available to other members of the research team including Dr. Craig Buchholz
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Throughout the study.
Access Criteria: Involved in data collection
Current Responsible Party Zylorion Health
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zylorion Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre Chue, MBBCh University of Alberta
PRS Account Zylorion Health
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP