Effects of S-ketamine on brain activation in healthy women, healthywomen prone to depression and fibromyalgia patients.

Recruiting

• Conditions: Ketamine, fMRI, fibromyalgia, depression

• Registration Number: NL-OMON28963
• Lead Sponsor: eiden University Medical Center, Leiden, The Netherlands

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: 60

Inclusion Criteria

Right-handed female participants 18-45 years old, naive to ketamine and pre-screened using the BDI-II (Beck Depression Inventory second edition).

Group 1: healthy, no history of depression and BDI score < 5.

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
Esketamine effects on brain activity and connectivity.<br>Esketamine, esnorketamine and eshydroxynorketamine plasma concentrations.

Secondary Outcome Measures

Name	Time	Method
Psychological measures to assess depression and pain symptoms.<br /><br>Visual Analogue Scale (VAS) to assess mood, alertness and calmness (Bond and Lader).<br /><br>VAS to assess psychedelic effects (Bowdle).<br>