CompletedPhase 2ACTRN12615000617561

Effects of glutamate modulation on anxiety symptoms

Effect of ketamine on anxiety ratings in patients with anxiety disorders

Sponsor

University of Otago

Enrollment

24 participants

Start Date

Nov 10, 2015

Study Type

Interventional

Conditions

Anxiety Disorders

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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 Criteria6

Female patients who are or intend to become pregnant, or are lactating
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).
Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
Current use of MAOIs, thyroxine or stimulants (amphetamine/methyphenidate). Use of antidepressants or other anxiolytics at stable doses > 4 weeks is acceptable.
Patients with severe acute or chronic medical illnesses.
Patients with current active suicidal ideation.

Interested in this trial?

Get notified about updates and connect with the research team.

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) o

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.