None listed
Conditions
Brief summary
Despite being described for over a century no effective psychological or medical treatment has emerged. This means there is no current effective/ evidence-based treatment for Psychogenic non-epileptic seizures (PNES) other than simply explaining the diagnosis. This study will look into the effectiveness of ketamine in treating PNES based on the idea that ketamine reduces the psychological trait neuroticism and patients with PNES have been shown to have high levels of this. Because there has been no previous research into treating patients with PNES with ketamine the trial involves a titration to find the right dose and is open label.
Interventions
Open label, uncontrolled, safety and acceptability study with weekly ketamine titration over 4 weeks (n=10). With a baseline seizure frequency measurement of 6 weeks both before and after a psychological explanation of the diagnosis and a 4-week measurement of seizure frequency after the ketamine intervention
Open label ketamine 1.0-2.0mg/kg oral weekly for 4 weeks (based on tolerability). Dosing schedule will be 1.0mg/kg in week 1, 1.5mg/kg in week two and 2.0mg/kg in week three and four.
M
Open label, uncontrolled, safety and acceptability study with weekly ketamine titration over 4 weeks (n=10). With a baseline seizure frequency measurement of 6 weeks both before and after a psychological explanation of the diagnosis and a 4-week measurement of seizure frequency after the ketamine intervention Open label ketamine 1.0-2.0mg/kg oral weekly for 4 weeks (based on tolerability). Dosing schedule will be 1.0mg/kg in week 1, 1.5mg/kg in week two and 2.0mg/kg in week three and four. Medication will be added to 50mL orange juice (to mask drug taste). Medication will be administered at the study site under direct supervision of investigator(s).
Sponsors
Department of Psychological medicine, Otago University
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 No maximum
Healthy volunteers
No
Inclusion criteria
1. Capable of understanding and signing an informed consent 2. Aged >18 years on the day of consent. 3. Have an established diagnosis of PNES by a neurologist and have failed to benefit from psychoeducation using the explanation suggested
Exclusion criteria
To be included in the study, participants must meet none of the following exclusion criteria: 1. Female participants who are or intend to become pregnant, or are lactating 2. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved). 3. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk. 4. Starting new antidepressants, anxiolytics or psychotherapy within 4 weeks of enrolment. Use of antidepressants, anxiolytics at stable doses > 4 weeks prior or psychotherapy is acceptable. 5. Participants with severe acute or chronic medical illnesses. 6. Participants with comorbid schizophrenia, bipolar disorder and severe personality disorders, comorbid depression and anxiety is acceptable 7. Participants with current drug or alcohol abuse problems 8. Participants with current active suicidal ideation 9. Participants with any current controlled or uncontrolled epileptic seizures as diagnosed by a neurologist
Outcome results
None listed