Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000722493p
Ethics application status
Submitted, not yet approved
Date submitted
23/06/2025
Date registered
7/07/2025
Date last updated
7/07/2025
Date data sharing statement initially provided
7/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine Plus Exposure Therapy For Post-Traumatic Stress Disorder (PTSD)– Open Label Pilot Study Targeting Anxiety
Scientific title
Ketamine Plus Exposure Therapy For Post-Traumatic Stress Disorder (PTSD)– Open Label Pilot Study Targeting Anxiety
Secondary ID [1] 314718 0
None
Universal Trial Number (UTN)
Trial acronym
K+PE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-Traumatic Stress Disorder 337919 0
Condition category
Condition code
Mental Health 334247 334247 0 0
Anxiety
Mental Health 334326 334326 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1: Oral ketamine: Week 1: Day 1 – 0.5mg/kg; day 2: 1mg/kg; day 3: 1.5mg/kg; days 4-7: 2mg/kg.
Weeks 2-11: Oral ketamine 2mg/kg twice weekly. All dosing will occur in the Fraser Building clinic.
All ketamine doses to be mixed with 100mL of orange juice which will be sipped over 30 minutes.
2: Psychotherapy: Prolonged Exposure sessions, once each week, weeks 2-11, usually 24h after oral ketamine dosing. Sessions last up to 2 hours. All sessions are 1-on-1 with a clinical psychologist. During the sessions, patients will be gradually and repeatedly exposed to trauma-related memories, feelings, and situations that they have been avoiding. All sessions will occur in the Fraser Building clinic.
We will monitor adherence for all clinic visits.
Intervention code [1] 331324 0
Treatment: Drugs
Intervention code [2] 331439 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341908 0
Anxiety
Timepoint [1] 341908 0
Days 1, 3 and 8 in week 1 (medication only week), then weekly between weeks 2-11 (medication plus psychotherapy treatment weeks).
Primary outcome [2] 341909 0
Suicidality
Timepoint [2] 341909 0
Weekly, weeks 1-11 post intervention commencement.
Secondary outcome [1] 448942 0
Bladder-related symptoms
Timepoint [1] 448942 0
Weekly, weeks 1-11 post intervention commencement.
Secondary outcome [2] 448946 0
Reported adverse events (e.g. sedation, light-headedness).
Timepoint [2] 448946 0
Weekly from weeks 1-11 post intervention commencement.

Eligibility
Key inclusion criteria
• Male or female aged between 18 and 50 years
• Capable of understanding and signing an informed consent
• Diagnosed with post-traumatic stress disorder (PTSD) with a PSSI-5 score >23.
• Patients must have had an inadequate response to prior treatment i.e. have not responded to at least two adequate trials of relevant medication and at least one trial of relevant psychotherapy.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• evidence of severe acute or chronic medical disorders,
• past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms
• current diagnosis of severe personality disorder
• female patients who are pregnant or lactating
• drug abuse or dependence in the last 6 months
• current significant suicidal ideation
• participants must be free of recreational drug and alcohol use at the time of testing

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
-Demographic and Background Characteristics: Patient demographics, background characteristics and trial data will be descriptively summarized for all subjects.
-PSSI-5 and safety data: Descriptive statistics for PSSI-5 (including the SD, which we will need to sample size estimation of the larger trial; although the estimate from n=12 will not be precise and we will use the upper 95% CI limit as a worst-case bound), acceptability, safety and tolerability endpoints. A 30% reduction in PTSD symptoms is considered clinically meaningful and will be used to identify those benefiting from treatment11. Bayesian analyses will be used to estimate the probability of within-person improvement (noting the absence of controls) at 12 weeks follow-up.)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/07/2025
Actual
Date of last participant enrolment
Anticipated
19/12/2025
Actual
Date of last data collection
Anticipated
24/04/2026
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 27136 0
New Zealand
State/province [1] 27136 0
Otago

Funding & Sponsors
Funding source category [1] 319273 0
Charities/Societies/Foundations
Name [1] 319273 0
James Hume Fund
Country [1] 319273 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321744 0
None
Name [1] 321744 0
Address [1] 321744 0
Country [1] 321744 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317848 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317848 0
Ethics committee country [1] 317848 0
New Zealand
Date submitted for ethics approval [1] 317848 0
23/06/2025
Approval date [1] 317848 0
Ethics approval number [1] 317848 0

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

Contacts
Principal investigator
Name 142346 0
Prof Paul Glue
Address 142346 0
University of Otago, PO Box 56, Dunedin 9054
Country 142346 0
New Zealand
Phone 142346 0
+64 3 470 9451
Fax 142346 0
Email 142346 0
[email protected]
Contact person for public queries
Name 142347 0
Paul Glue
Address 142347 0
University of Otago, PO Box 56, Dunedin 9054
Country 142347 0
New Zealand
Phone 142347 0
+64 3 470 9451
Fax 142347 0
Email 142347 0
[email protected]
Contact person for scientific queries
Name 142348 0
Paul Glue
Address 142348 0
University of Otago, PO Box 56, Dunedin 9054
Country 142348 0
New Zealand
Phone 142348 0
+64 3 470 9451
Fax 142348 0
Email 142348 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Health economic analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.