None listed
Conditions
Brief summary
Bipolar depression is often persistent and disabling with limited treatment options. Ketamine is a pain-relief and anaesthetic medication that has emerged as a new treatment for standard or non-bipolar depression. Some early studies suggest that ketamine may also help bipolar depression but these were short-term and involved ketamine injections. This study seeks to see if it is feasible to treat bipolar depression with a course of oral ketamine. We also seek to determine any mood improvements and the safety and tolerability of the ketamine course.
Interventions
Oral ketamine will be administered twice-weekly in the clinical research units of the Departments of Psychological Medicine (Dunedin or Christchurch) for a total of 8-weeks. Each dose will be administered under the oversight of a healthcare professional. Oral ketamine dose will be determined by the MADRS and tolerability using an established protocol as follows.
Oral Ketamine to commence at 1 mg/kg mixed with 50 ml orange juice and sipped over 30–60 minutes. Initial dosing twice weekly (with g
Oral ketamine will be administered twice-weekly in the clinical research units of the Departments of Psychological Medicine (Dunedin or Christchurch) for a total of 8-weeks. Each dose will be administered under the oversight of a healthcare professional. Oral ketamine dose will be determined by the MADRS and tolerability using an established protocol as follows. Oral Ketamine to commence at 1 mg/kg mixed with 50 ml orange juice and sipped over 30–60 minutes. Initial dosing twice weekly (with gaps of 3 and 4 days between doses). If first dose is tolerated and if the Montgomery Asberg Depression Rating Scale (MADRS)>6 on follow-up (indicating mild depression or greater), increase dose to 1.5 mg/kg twice weekly. If second dose is tolerated and if the MADRS>6 on follow-up, increase dose to 2 mg/kg twice weekly. If the MADRS is <6 on follow-up, dosing can be reduced to weekly intervals. Dosing to be supervised by administering clinician (study nurse or doctor) and discussed with the supervising psychiatrist as needed and if ketamine is not tolerated.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Age 18-65 years. • Diagnosis of Bipolar I or II Disorder according to DSM-5 (American Psychiatric Association, 2013) criteria. • Current Major Depressive Episode according to DSM-5 (American Psychiatric Association, 2013) criteria. • On stable psychiatric medications for at least 4 weeks prior to screening. Bipolar 1 disorder patients required to be on mood stabilising treatment (recommended doses of an antipsychotic medication, lithium carbonate, or sodium valproate). Maintenance treatment with lamotrigine only is not sufficient (because it typically has limited efficacy for preventing mood elevation) unless individual circumstances suggest there has been an extended period of stability on lamotrigine without other mood stabilisers.
Exclusion criteria
• History of current or recent substance disorder within the past 6 months (excluding nicotine use disorder and mild cannabis use disorder). • Diagnosis of primary psychotic disorder. • Moderate-severe personality disorder. • Severe acute or chronic medical conditions. • Current or recent significant suicidal intent or self-harm behaviour. • Bladder pathology. • Inability to participate provide informed consent and/or participate in study procedures. • Pregnancy or lactation. • Prior serious head injury or other neurological condition causing ongoing cognitive impairment. • Young Mania Rating Scale (YMRS) > 8 (Young et al., 1978) (to rule out mixed states). • Previous poor response to ketamine.
Outcome results
None listed