None listed
Conditions
Brief summary
Differences in brain function will be investigated in participants with treatment-resistant social anxiety disorder (SAD) and/or generalised anxiety disorder (GAD). Participants will be dosed with ketamine, a drug believed to have fast-acting effects on mood in patients with treatment-resistant anxiety. It is hypothesised that predictors of successful ketamine treatment response will be identified using precision functional mapping. This research will contribute to a future in which patients receive individually tailored medical care, leading to a better quality of life (precision medicine).
Interventions
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 72 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 an
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 72 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.
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 45 Years
Healthy volunteers
No
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.
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
Outcome results
None listed