Unipolar Depression
Conditions
Brief summary
This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.
Interventions
DRUGKetamine
DRUGPlacebo
Sponsors
University of Sydney
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Individuals will be eligible for enrolment on the basis of: * major depressive disorder for at least three months duration * an inadequate response to at least 2 adequate antidepressants * MADRS ≥ 20 Patients will be excluded on the basis of: * History of psychosis * History of bipolar disorder * Any unstable medical or neurologic condition * Any Axis I disorder other than MDD judged to be primary presenting problem * Planned major changes to psychotropic medication * Significant risk of suicide * Planned or probable use of ECT * Age under 16 years, or 16-17 years without parental consent * Substance abuse or dependence in previous 6 months * Any history of abuse of ketamine or phencyclidine * Contraindication to the use of ketamine * Planned use of ketamine * Women of childbearing potential not taking reliable contraception * Likely non-compliance with trial treatment * Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asberg Depression Rating Scale for Depression (MADRS) | 4 weeks |
Countries
Australia
Outcome results
None listed