Positioning of Esketamine Treatment in the Real-world Management of Depression
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRoyal North Shore Hospital
About this trial
The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are:
* to investigate whether Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice
Participants will:
* attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses
Eligibility criteria
Qualifiers
Adults aged 18-65 years old
Diagnosis of Major Depressive Disorder (MDD)
Currently depressed
Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)
Disqualifiers
Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia
Participants who are unable to understand the study and therefore unable to provide informed consent
Participants who are pregnant and/or breastfeeding
Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods
Trial design
Treatments tested in this trial
- Esketamine Nasal Spray [Spravato]
Treatment groups
162 Participants
are divided into 1 treatment groupSponsors and collaborators
Royal North Shore Hospital
Lead sponsor
Janssen-Cilag Pty Ltd
Collaborator
Source ClinicalTrials.gov