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.

Recruiting

• Conditions: Depression; unhappiness; 10027946

• Registration Number: NL-OMON49216
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 63

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Brain activation: degree of increase or decrease by ketamine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Psychological measures to assess depression.</p><br>