Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) Nervous System Diseases
Conditions
Interventions
Participants undergo an MRI scan, which allows the measurement of lactate. During this scan, they undergo a simple task, which includes looking at the flickering checkerboard for 7.5 min
this is preceded and followed by 11 min of rest with eyes closed. Participants are also asked to fill out a number of questionnaires to collect information about their symptoms.
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Males or females aged 18 years or over 2. Willing and able to give informed consent to participate in the study 3. Diagnosis of DSM-V major depression based on the affective disorder sections of the SCID-5. N.b. comorbid anxiety disorder is not an exclusion criterion 4. Quick Inventory of Depressive Symptomatology self-report version (QIDS-SR16) score >10 (moderate, severe or very severe depression) 5. Currently taking an antidepressant medication and on a stable dose of an antidepressant for at least 4 weeks 6. A lack of response to at least two antidepressants at therapeutic doses (based on Maudsley Prescribing Guidelines and/or British National Formulary) in the current episode (including the current one) 7. An indication for a change in treatment 8. Willing to continue antidepressant treatment 9. Having access to a smartphone 10. Women of child-bearing potential (WOCBP) only – a negative urine pregnancy test result
Exclusion criteria
Exclusion criteria: 1. Clinical diagnosis of current or previous psychosis (including psychotic depression), bipolar disorder or Parkinson’s Disease 2. Currently taking an antipsychotic medication 3. Clinically significant current or previous impulse control difficulties 4. Serious suicide or homicide risk 5. Current treatment with any medication known to interfere with pramipexole metabolism including cimetidine, memantine and methyldopa 6. Contraindications to pramipexole including history of or current treatment for glaucoma or retinal degeneration, significant, symptomatic cardiovascular or renal disease or significant, symptomatic orthostatic hypotension 7. Previous course of pramipexole (>2 weeks) 8. Untreated or unstable medical condition which, in the judgement of the investigator, could interfere with the safety of receiving pramipexole or ability to complete the study 9. Pregnancy, breast-feeding or planning pregnancy 10. WOCBP not willing to use effective contraception 11. Male participants not willing to refrain from donating sperm 12. Planning to start other mental health treatments or psychotherapy started in past 4 weeks or planned to start within next 12 weeks 13. Participants will be excluded if they participated in a psychological or medical study involving the same reward processing tasks within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lactate concentration in the occipital cortex from basline to stimulation with flashing checkeboard using functional MRS - ME/CFS patients compared to healthy controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting lactate concentration in the anterior cingulate cortex measured with MRS - ME/CFS patients compared to healthy controls. | — |
Countries
England, United Kingdom
Contacts
Public ContactBeata;Philip Godlewska;Cowen
;
Outcome results
None listed