Status:
TERMINATED
Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression
Lead Sponsor:
Zylorion Health
Conditions:
Treatment Resistant Major Depressive Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT05323019
Start Date
October 13 2022
End Date
February 1 2023
Last Update
March 24 2023
Active Locations (1)
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1
City Center Pharmacy and Medical Clinic
Edmonton, Alberta, Canada, T5J 5C2