Status:
COMPLETED
Investigation of Intranasal Ketamine Related Changes in Attentional Brain Networks With Functional and Structural MRI
Lead Sponsor:
Rupert Lanzenberger
Conditions:
Ketamine Treatment
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Subanesthetic ketamine is currently used as a rapid-acting antidepressant. It is an antagonist of the N-methyl-d-aspartate (NMDA) receptor, but former results indicate that its action also depends on ...
Eligibility Criteria
Inclusion
- General health (no serious internal or neurologic pre-existing conditions) based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
- Age 18 to 55 years
- Right-handedness (due to potential lateralization effects of left-handed subjects)
- Willingness and competence to sign the informed consent form
Exclusion
- Current or history of psychiatric or neurological disease
- Current medical illness requiring treatment
- Current or former substance abuse
- Pregnancy or current breastfeeding
- Diagnosis of an Axis-1 psychotic disorder in a first-degree relative
- Known aneurysmal vascular disease based on medical history (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels), history of intracerebral haemorrhage, recent (within 6weeks) cardiovascular event, including myocardial infarction (MI)
- Significant pulmonary insufficiency, including COPD; sleep apnoea with morbid obesity (BMI ≥35), uncontrolled brady- or tachyarrhythmias that lead to haemodynamic instability; history of an MI, haemodynamically significant valvular heart disease or heart failure (NYHA Class III-IV)
- Hyperthyroidism that has not been sufficiently treated
- History of brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure
- Child-Pugh class C (severe) hepatic impairment
- Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts
- Failure to comply with the study protocol or to follow the instruction of the investigating team
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05320120
Start Date
June 1 2022
End Date
June 21 2023
Last Update
April 15 2024
Active Locations (1)
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1
Department of Psychiatry and Psychotherapy
Vienna, Austria, 1090