None listed
Conditions
Brief summary
The glutamate antagonist ketamine has rapid onset antidepressant effects in patients with treatment-resistant depression. Patients with OCD and PTSD have had similarly rapid improvement in symptoms when administered ketamine. This study will assess if similar improvements occur in patients with GAD and SP.
Interventions
This study has three Phases
1. Open label within-subject ascending single dosing of ketamine (dose range 0.25, 0.5, 1 mg/kg subcutaneously (SC)) in patients with Generalized Anxiety Disorder (GAD) or Social Phobia (SP) (n=6/diagnosis). Unless there are individual toleration problems, it is anticipated all patients will receive all doses. There will be approximately 1 week between doses.
2. Double-blind within-subject ascending single dosing of ketamine (dose range 0.25, 0.5, 1 mg/kg subcutaneou
This study has three Phases 1. Open label within-subject ascending single dosing of ketamine (dose range 0.25, 0.5, 1 mg/kg subcutaneously (SC)) in patients with Generalized Anxiety Disorder (GAD) or Social Phobia (SP) (n=6/diagnosis). Unless there are individual toleration problems, it is anticipated all patients will receive all doses. There will be approximately 1 week between doses. 2. Double-blind within-subject ascending single dosing of ketamine (dose range 0.25, 0.5, 1 mg/kg subcutaneously) plus double blind active control (midazolam 0.01mg/kg SC) in a separate group of patients with GAD or SP (n=6/diagnosis). The timing of the midazolam dose will be randomized within the ascending ketamine doses. There will be approximately 1 week between doses. 3. Patients will be eligible to enter Phase 3 once they have completed either Phase 1 or Phase 2; entry to Phase 3 will be immediately after completing Phase 1 or Phase 2. They must also have had at least 50% reduction in anxiety ratings in response to any dose of ketamine are eligible to receive 1-2x weekly ketamine dosing for up to 3 months to help maintain improvement in anxiety symptoms. The Phase 3 dose will be individualized based on the balance between optimal tolerability and efficacy.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
GAD patients must have a Hamilton Anxiety Scale (HAM-A) score >20 SP patients must have a Liebowitz Social Anxiety Scale (LSAS) self-report score >50.
Exclusion criteria
1.Female patients 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.Current use of MAOIs, thyroxine or stimulants (amphetamine/methyphenidate). Use of antidepressants or other anxiolytics at stable doses > 4 weeks is acceptable. 5.Patients with severe acute or chronic medical illnesses. 6.Patients with current active suicidal ideation.
Outcome results
None listed