Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001127897p
Ethics application status
Submitted, not yet approved
Date submitted
29/06/2021
Date registered
23/08/2021
Date last updated
23/08/2021
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study of ketamine in pyschogenic non-epileptic seizures.
Scientific title
Ketamine treatment for psychogenic non-epileptic seizures
Secondary ID [1] 304147 0
nil
Universal Trial Number (UTN)
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
Psychogenic non-epileptic seizures 321844 0
Condition category
Condition code
Neurological 319569 319569 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 320928 0
Treatment: Drugs
Comparator / control treatment
No controlled group, safety and acceptability study only
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327989 0
Change in average NES frequency as measured with a seizure diary
Timepoint [1] 327989 0
From participants entry until 16 weeks with daily entry to diary for seizure activities
Secondary outcome [1] 397168 0
Tolerability (vital signs and adverse drug reactions)
- Vital signs of pulse, blood pressure, and self reported symptoms of nausea or vomiting
- These will be measured by clinician/s with:
* Palpation for pulse
* Sphygmomanometer (Digital or manual) for blood pressure
* Self reporting with 5-point Likert Scale for nausea
* Self reporting with number of episodes for vomiting
Timepoint [1] 397168 0
Week 1, 2, 3, and 4, at the time immediately prior to dose, 15 minutes, 30 minutes and 60 minutes post dose
Week 10, 11, 12, 13 and 14
Secondary outcome [2] 397169 0
Clinician Administered Dissociative Symptoms Scale (CADSS)
Timepoint [2] 397169 0
During week 1, 2, 3 and 4: 30 minutes prior to and 30 minutes after dose
Secondary outcome [3] 399133 0
Stop Signal Task
Timepoint [3] 399133 0
At day one screening time
Secondary outcome [4] 399134 0
Work and Social Adjustment Scale (WSAS)
Timepoint [4] 399134 0
At day one, week 4 and end of study
Secondary outcome [5] 399135 0
36-Item short form survey (SF-36)
Timepoint [5] 399135 0
At day one, week 4 and end of study
Secondary outcome [6] 399136 0
Eysenck Personality Questionnaire Neuroticism subscale (EPQ-N)
Timepoint [6] 399136 0
At day one and end of study
Secondary outcome [7] 399137 0
10-minute relaxation EEG
Timepoint [7] 399137 0
During week 1 and 4: 30 minutes prior to and 60 minutes after dose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Nil
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Demographic and Background Characteristics: Participant demographic, background characteristics and trial data will be descriptively summarized for all participants.
Average seizure frequency per week will be compared between baseline intervention and follow-up states using ANOVA or non-parametric alternative test.

Statistical power calculations are constrained by the stage of development (this is a proof-of-concept study) and the absence of data on use of ketamine in PNES. We reason that if fewer than 4 out of the 10 participants do not show a significant reduction in seizure frequency (at least 50%) than the effect of ketamine is likely to be of limited clinical value.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 23823 0
New Zealand
State/province [1] 23823 0
Otago

Funding & Sponsors
Funding source category [1] 308521 0
University
Name [1] 308521 0
Otago Unverisity
Country [1] 308521 0
New Zealand
Primary sponsor type
University
Name
Department of Psychological medicine, Otago University
Address
464 Cumberland Street, Dunedin Central, Dunedin 9016, Otago, New Zealand
Country
New Zealand
Secondary sponsor category [1] 309866 0
None
Name [1] 309866 0
Address [1] 309866 0
Country [1] 309866 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308477 0
Southern Health and Disability Ethics Committee (New Zealand)
Ethics committee address [1] 308477 0
Ethics committee country [1] 308477 0
New Zealand
Date submitted for ethics approval [1] 308477 0
30/06/2021
Approval date [1] 308477 0
Ethics approval number [1] 308477 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110830 0
Dr Charlotte Mentzel
Address 110830 0
Department of Psychological Medicine
Otago Medical School
Division of Health Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 110830 0
New Zealand
Phone 110830 0
+64 3 470 9451
Fax 110830 0
Email 110830 0
[email protected]
Contact person for public queries
Name 110831 0
Charlotte Mentzel
Address 110831 0
© Department of Psychological Medicine
Otago Medical School
Division of Health Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 110831 0
New Zealand
Phone 110831 0
+64 3 470 9451
Fax 110831 0
Email 110831 0
[email protected]
Contact person for scientific queries
Name 110832 0
Charlotte Mentzel
Address 110832 0
© Department of Psychological Medicine
Otago Medical School
Division of Health Sciences
PO Box 56
Dunedin 9054
New Zealand
Country 110832 0
New Zealand
Phone 110832 0
+64 3 470 9451
Fax 110832 0
Email 110832 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.