Evaluation of brain glutamatergic mechanisms in patients with treatment resistant anxiety

Evaluation of brain glutamatergic mechanisms in patients with treatment resistant anxiety - comparative effects of ketamine vs fentanyl

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001177347

Acronym

N/A

Enrollment

Registered

2017-08-10

Start date

2017-10-01

Completion date

2019-10-01

Last updated

2017-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Low-dose ketamine has fast-acting positive effects on mood in patients with treatment resistant anxiety, similar to its effects in depression. This is a mechanistic study to assess changes in brain function in patients with treatment resistant anxiety treated with ketamine or a psychoactive control, using a range of assessment methods (brain imaging, EEG analysis, blood pharmacokinetic samples). Data from this study may help clarify the neurobiological basis of treatment-resistant anxiety.

Interventions

Single doses of ketamine 1mg/kg as intramuscular injections

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

• Male or female aged 18-65y • Diagnosed with DSM-5 Generalized Anxiety Disorder and/or Social Anxiety Disorder, with inadequate response to prior treatment i.e. unsuccessful with 1 or more prescribed antidepressants and prior failed psychotherapy • Hamilton Anxiety Scale (HAM-A) score of >20, and/or a Liebowitz Social Anxiety Scale (LSAS) score of >60 at screening. • Prior response to ketamine as demonstrated by a >50% decrease in HAMA and/or Fear Questionnaire (FQ) scores 24 hours after dosing.

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 Major Depressive Disorder (MADRS >20 at screening). • participants must be free of recreational drug and alcohol use at the time of testing

Outcome results