Objective 1: To determine the effects of S-ketamine on brain activation in healthy women, healthy women prone to depression and fibromyalgia patients.Objective 2: To determine the effects of S-ketamine on mood and other depression-related behavioral…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Brain activation: degree of increase or decrease by ketamine.
Secondary outcome
Psychological measures to assess depression.
Background summary
The NMDA receptor antagonist ketamine is used as an anesthetic, painkiller and,
more recently, also as an antidepressant, even though the neural mechanism of
its antidepressant action is still unknown. Ketamine causes rapid improvements
in mood and suicidality in treatment-resistant patients (Berman et al., 2000;
Caddy, Giaroli, White, Shergill, & Tracy, 2014; Krystal, Sanacora, & Duman,
2013; Murrough et al., 2013; Singh et al., 2016; Zarate et al., 2006). However,
the effects of ketamine in groups of depressed patients other than
treatment-resistant / severely depressed, are still unknown. Previously, we
investigated the effects of S(+)-ketamine on brain activation in healthy male
participants (protocol nr P10.136) but the results are difficult to extrapolate
to depressed patients as well as to women. To further elucidate the (neural)
mechanisms of ketamine, which may underlie its (rapid) antidepressant response,
we will investigate the effects of ketamine on brain activation in healthy
women, women prone to depression and fibromyalgia patients.
Study objective
Objective 1: To determine the effects of S-ketamine on brain activation in
healthy women, healthy women prone to depression and fibromyalgia patients.
Objective 2: To determine the effects of S-ketamine on mood and other
depression-related behavioral meaures.
Study design
Placebo-controlled crossover.
Intervention
Intravenous administration of S(+)-ketamine (0.4 mg/kg) and placebo.
Study burden and risks
Mild to moderate: psychomimetic side effects during exposure to ketamine.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-003913-91-NL |
| CCMO | NL59356.058.16 |