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.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49216

Enrollment

Registered

2019-09-03

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

Depression unhappiness

Interventions

Intravenous administration of S(+)-ketamine (0.4 mg/kg) and placebo.

Depression

Ketamine

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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
Brain activation: degree of increase or decrease by ketamine.	—

Secondary

Measure	Time frame
Psychological measures to assess depression.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)