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

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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28963

Enrollment

Registered

2018-08-23

Start date

2017-11-07

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Ketamine, fMRI, fibromyalgia, depression

Interventions

Esketamine 0.4 mg/kg or placebo will be administered intravenously in 40 minutes.

Eligibility

Inclusion criteria

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. 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

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.

Design outcomes

Primary

Measure	Time frame
Esketamine effects on brain activity and connectivity. Esketamine, esnorketamine and eshydroxynorketamine plasma concentrations.	—

Secondary

Measure	Time frame
Psychological measures to assess depression and pain symptoms. Visual Analogue Scale (VAS) to assess mood, alertness and calmness (Bond and Lader). VAS to assess psychedelic effects (Bowdle).	—

Contacts

Public ContactAlbert Dahan

Leiden University Medical Center (LUMC), Department of Anesthesiology, P.O. Box 9600

a.dahan@lumc.nl+31 (0)71 5262301

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)