Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression

NCT05323019 | Terminated Phase 2 DMC

• 1 other identifier: HREBA-CTC-22-0015
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in the Montgomery Asberg Depression Rating Scale (MADRS) from screening to Day 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

  Screening, Day 7, 14, 21 and 28

Secondary Outcomes (5)

• Change in Post-traumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5)

  Screening and Day 28

• Change in Patient Health Questionnaire (PHQ-9)

  Screening, Day 2, 5, 9, 12,16, ,19, 23, 26 and 28

• Change in Generalized Anxiety Disorder Questionnaire (GAD-7)

  Screening, Day 2, 5, 9, 12, 16, 19, 23, 26 and 28

• Change in Rosenberg Self-Esteem Questionnaire (RSES)

  Screening and Day 28

• Change in Quality of Life 8 Dimensional Questionnaire (AQoL-8D)

  Screening and Day 28

Study Arms (2)

Intranasal (esketamine) Ketamine with Addition of Almond therapy

OTHER

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.

Behavioral: Psychotherapy; Drug: Intranasal Ketamine (esketamine)

Intranasal (esketamine) Ketamine with Treatment as Usual

OTHER

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.

Behavioral: Treatment as Usual; Drug: Intranasal Ketamine (esketamine)

Interventions

Psychotherapy BEHAVIORAL

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.

Intranasal (esketamine) Ketamine with Addition of Almond therapy

Treatment as Usual BEHAVIORAL

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.

Intranasal (esketamine) Ketamine with Treatment as Usual

Intranasal Ketamine (esketamine) DRUG

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

Also known as: Spravato

Intranasal (esketamine) Ketamine with Addition of Almond therapy; Intranasal (esketamine) Ketamine with Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zylorion Health: lead

Study Sites (1)

City Center Pharmacy and Medical Clinic

Edmonton, Alberta, T5J 5C2, Canada

Location

MeSH Terms

Interventions

Psychotherapy; Therapeutics; Esketamine

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Pierre Chue, MBBCh

  Amygdala Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized by a pre-specified block design method after confirming eligibility.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 12, 2022
• Study Start: October 13, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Throughout the study.
• Access Criteria: Involved in data collection

Locations

CA (1)