A randomised, double blind, placebo-controlled cross-over study to investigate the effects of intravenous S(+)-ketamine on brain activation in three groups of women: healthy participants, healthy participants prone to depression and patients with fibromyalgia. - SoKET

eids Universitair Medisch Centrum0 个研究点目标入组 63 人开始时间: 待定最近更新: 2024年2月28日

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•Right-handed female participants 18-45 years old, naive to ketamine and pre-screened using the M.I.N.I (Mini International Neuropsychiatric Interview version 5.0.0) and BDI-II (Beck Depression Inventory second edition). Group 1: healthy, no history of depression as indicated by the M.I.N.I. and BDI score < 5. Group 2: prone to depression: currently only sub-clinical symptoms indicated by a BDI score ranging from 5 to 17, but previous episode (1 or 2) of clinical depression as indicated by the M.I.N.I. Group 3: pain patients diagnosed with fibromyalgia (meet the 2010 American College of Rheumatology diagnostic criteria), who also show sub-clinical symptoms of depression as indicated by the M.I.N.I. and a BDI score ranging from 5 to 17.

•Currently clinically depressed and/or on antidepressant medication; obesity (BMI > 30); significant history of any cardiac or vascular disorder, asthma or other pulmonary disease, major gastrointestinal abnormalities, peptic ulceration, hepatic, neurological, psychiatric, haematological (including bleeding disorders), endocrine, renal, or major genitourinary disease.
•History of chronic alcohol or illicit drug use; the contraindications for MRI as defined by the MR safety committee of the department of Radiology, LUMC; claustrophobia; the presence of pain syndromes other than fibromyalgia.

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