An open-label feasibility study of ketamine-assisted therapy.
- Conditions
- treatment-resistant depressionMental Health - Depression
- Registration Number
- ACTRN12621000562875
- Lead Sponsor
- niversity of Auckland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Adult patients who meet DSM-5 criteria for Major Depressive Disorder or Bipolar Disorder and:
1) will and able to give informed consent for participation in the study
2) Male or female, aged 18 years or above and less than age 70.
3) If Bipolar Disorder must be on a mood stabilizing medication for the duration of the study
4) current depressive episode for at least three months
5) MADRS > or = 20
6) Inadequate response to at least two antidepressant treatments one of which can include the current episode.
7) must be stable on any psychotropic medication for at least four weeks prior to the study day.
Participant may not enter the trial if ANY of the following apply:
•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
•Significant renal or hepatic impairment.
•Cardiovascular conditions including severe cardiovascular disease, heart failure, severe or poorly controlled hypertension, recent myocardial infarction, history of stroke, cerebral trauma, or intracerebral mass or haemorrhage.
•Abnormal heart rate or blood pressure checked at screening.
•Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
•History of significant psychotic episode(s).
•Any unstable medical or neurologic condition.
•Planned major changes to psychotropic medication.
•Imminent risk of suicide as determined by the CSSRS and MADRS/clinical interview.
•Planned or probable use of ECT.
•Active substance use disorder in the previous 6 months.
•Regular use of any medication deemed to be contraindicating as judged by the attending study physicians
•Inability to speak or read English.
•Any history of abuse of ketamine or phencyclidine.
•Contraindication to the use of ketamine according to manufacturer guidelines including hypersensitivity to the drug or its components.
•Planned use of ketamine, for example, for pain control.
•Unable to fast for four hours prior to administration of ketamine.
•Any other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial.
•Body-weight <50kg or >120kg.
•Current use of the following medications:memantine / amantadine / rimantadine / dextromethorphan/procyclidine/ lamotrigine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method