Actively Recruiting
Positioning of Esketamine Treatment in the Real-world Management of Depression
Led by Royal North Shore Hospital · Updated on 2024-05-17
162
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
Sponsors
R
Royal North Shore Hospital
Lead Sponsor
J
Janssen-Cilag Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Positioning of Esketamine Treatment in the Real-world Management of Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Maintained on current antidepressant medication or psychological therapy at enrollment
- Able to understand and provide informed consent
You will not qualify if you...
- Diagnoses of other DSM-5 disorders such as current substance misuse disorder, bipolar disorder, or schizophrenia
- Unable to understand the study or provide informed consent
- Pregnant or breastfeeding
- Unwilling to use effective birth control during the study
- Taking benzodiazepines exceeding 6 mg/day lorazepam equivalent
- Using complementary and alternative medicine therapies like St John's wort, Chinese medicines, or homeopathic treatments
- Taking stimulants such as methylphenidate, amphetamine, or dextroamphetamine concurrently with Esketamine
- History of seizures (except uncomplicated childhood febrile seizures)
- History of uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Aneurysmal vascular disease or related conditions
- Untreated glaucoma, penetrating eye injury, brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, increased intracranial or intraocular pressure, or planned eye surgery
- Current or recent (past month) electroconvulsive therapy (ECT)
- Lifetime substance misuse disorder involving ketamine, PCP, LSD, MDMA, or other hallucinogens
- Hypersensitivity to Esketamine, Ketamine, or any excipients
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
Research Team
E
Erica Bell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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