Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000497303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/03/2026
Date registered
Help: Date registered
22/04/2026
Date last updated
Help: Date last updated
29/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
22/04/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Mapping Individual Functional Brain Activity Patterns in People with Treatment-Resistant Anxiety Disorders After Treatment with Ketamine
Scientific title
Precision Functional Mapping of the Human Brain using Resting State functional Magnetic Resonance Imaging – Ketamine Validation Study Among Participants with Treatment-Resistant Social Anxiety Disorder (SAD) and/or Generalised Anxiety Disorder (GAD)
Additional trial identifiers [1] 316862 0
Nil known
Universal Trial Number (UTN)
U1111-1337-9713
Trial acronym
PFM
Related trial records

Health condition
Health condition(s) studied:
Treatment Resistant Anxiety 341237 0
Generalised Anxiety Disorder 341238 0
Social Anxiety Disorder 341241 0
Condition category
Condition code
Mental Health 337333 337333 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Single Dose Intramuscular Ketamine.

Single-Arm Study:

Participants will receive a single intramuscular dose of ketamine (1 mg/kg) at Visit 1 (approx. 3 hours), with a follow-up visit (Visit 2) (approx. 1 hour) completed approximately 24 hours later. Participants will complete an MRI during both Visit 1 and Visit 2.

During visit 1, participants will be screened and complete clinical assessment. MRI will then be completed (pre-ketamine) by staff at Pacific Radiology, Dunedin. Structural MRI and resting-state fMRI data will be collected. Participants will then receive ketamine 1mg/kg intramuscular. Dosing will occur in the Fraser Building clinical laboratory, and will be completed by either our study clinician or a research nurse. Resuscitation facilities (ambu bag) and appropriately trained staff will be available pre-dose until a minimum of 2 hours after dosing and until patients have met the safety requirements of the discharge checklist. During visit two, only clinical assessment and MRI will be completed.

Study staff/researchers will be present during the completion of all protocol to ensure adherence/fidelity to the intervention.

We will investigate changes in functional connectivity associated with clinical response to Ketamine, using resting state fMRI, in those with treatment-resistant anxiety.
Intervention code [1] 333563 0
Treatment: Drugs
Intervention code [2] 333582 0
Early detection / Screening
Description of the comparator or control
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 344853 0
Change in Functional Connectivity
Timepoint [1] 344853 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Primary outcome [2] 344872 0
Change in Anxiety
Timepoint [2] 344872 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Primary outcome [3] 344873 0
Change in Anxiety
Timepoint [3] 344873 0
Visit One (Pre-Dose) and Visit Two (22 hours Post-Dose)
Secondary outcome [1] 459510 0
Change in Fear
Timepoint [1] 459510 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [2] 459514 0
Change in Dissociative Symptoms
Timepoint [2] 459514 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [3] 459519 0
Change in Depression
Timepoint [3] 459519 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [4] 459520 0
Cognitive Function
Timepoint [4] 459520 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [5] 460052 0
Cognitive Function
Timepoint [5] 460052 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [6] 460053 0
Safety
Timepoint [6] 460053 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [7] 460055 0
Safety
Timepoint [7] 460055 0
Visit One (Pre-Dose) and Visit Two (24 hours Post-Dose)
Secondary outcome [8] 460056 0
Safety
Timepoint [8] 460056 0
Visit One (Post-Dose). Prior to enrolment commencement.

Eligibility
Key inclusion criteria
Inclusion Criteria:

To be included in the study, participants must meet all of the following inclusion criteria:
• Male or female aged between 18 and 45 years.
• Diagnosed with DSM-5 Generalised Anxiety Disorder and/or Social Anxiety Disorder, with inadequate response to prior treatment i.e. At least two separate failed full trials of pharmacological monotherapy (first-line treatments approved for treatment of anxiety disorders, duration of at least 6-8 weeks each, at least at the minimum dose) and/or prior failed trial of psychotherapy (Domschke et al., 2024). This will capture those with treatment-resistant anxiety.
• Hamilton Anxiety Scale (HAM-A (25)) score of >20, and/or a Liebowitz Social Anxiety Scale (LSAS (26)) score of >60 at screening. This will capture moderate to severe GAD and/or SAD.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion Criteria:

To be included in the study, participants must meet none of the following exclusion criteria:
• evidence of severe acute or chronic medical disorders
• presence of implanted cardiac pacemakers, hearing aids, insulin pumps or neurostimulators; intracranial metal clips; or metallic bodies in the eye
• past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms
• female patients who are pregnant or lactating
• drug abuse or dependence in the last 6 months
• current significant suicidal ideation
• current moderate to severe Major Depressive Disorder (MADRS >20 at screening).
• 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 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2026
Actual
Date of last participant enrolment
Anticipated
18/12/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 27964 0
New Zealand
State/province [1] 27964 0
Dunedin

Funding & Sponsors
Funding source category [1] 321463 0
University
Name [1] 321463 0
University of Otago
Country [1] 321463 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 324210 0
Hospital
Name [1] 324210 0
Te Whatu Ora - Southern
Address [1] 324210 0
Country [1] 324210 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319995 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 319995 0
Ethics committee country [1] 319995 0
New Zealand
Date submitted for ethics approval [1] 319995 0
25/03/2026
Approval date [1] 319995 0
12/06/2026
Ethics approval number [1] 319995 0
2026 FULL 25753

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

Contacts
Principal investigator
Name 149082 0
Prof Bruce R Russell
Address 149082 0
18 Frederick Street, Central Dunedin, Dunedin 9016 (Adams Building) - School of Pharmacy, University of Otago
Country 149082 0
New Zealand
Phone 149082 0
+64 3 479 7272
Fax 149082 0
Email 149082 0
[email protected]
Contact person for public queries
Name 149083 0
Brydie Dumelow
Address 149083 0
18 Frederick Street, Central Dunedin, Dunedin 9016 (Adams Building) - School of Pharmacy, University of Otago
Country 149083 0
New Zealand
Phone 149083 0
+64 3 479 7275
Fax 149083 0
Email 149083 0
[email protected]
Contact person for scientific queries
Name 149084 0
Bruce R Russell
Address 149084 0
18 Frederick Street, Central Dunedin, Dunedin 9016 (Adams Building) - School of Pharmacy, University of Otago
Country 149084 0
New Zealand
Phone 149084 0
+64 3 479 7272
Fax 149084 0
Email 149084 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: We will be doing our own analysis. Data will not be publically shared.



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.