Major depressive disorder
Conditions
Interventions
30 minutes of PEMF to the head, 5 days per week, 5 weeks in a row.
The control group will receive sham treatment meaning the stimulator will be applied but no actual stimulation will be given.
Sponsors
University Medical Center Groningen
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of MDD, first or recurrent major depressive episode (MDE), as established by MINI-Interview; 2. Age range: 18-80 years; 3. At least moderately severe depression (>17 on HAMD17); 4. Not having responded (i.e. maintained in a MDE) to at least two antidepressants during the current episode, both given for at least four weeks and in an adequate dose (i.e. the defined daily dose (DDD) (Ruhe et al 2012); 5. Good understanding of spoken and written Dutch; 6. In-patient or out-patient.
Exclusion criteria
Exclusion criteria: 1. Presence of a relevant neurological disorder such as dementia or epilepsy; 2. Other relevant major psychiatric disorders such as a primary psychotic disorder or an antisocial or borderline personality disorder; 3. Major depressive episode with psychotic features; 4. Visual or hearing problems that cannot be corrected; 5. Suicidal thoughts (>2 on HAMD17 for suicidal ideation) or a previous serious suicide attempt; 6. Recent (past three months) alcohol or drug abuse or dependence; 7. Pregnancy, lactation; 8. Inability to comply with treatments and/or assessments; 9. Recent change (last four weeks) in antidepressant medication or requirement to change antidepressant medication during the course of the study; 10. Use of mood stabiliser (lithium or anticonvulsant) or antipsychotic within the last four weeks or during the course of the study; 11. Use of benzodiazepine(s) in excess of 2 mg lorazepam (or equivalent) per day within the last four weeks or during the course of the study; 12. Use of somatic medication that may affect mood within the last four weeks; 13. Excessive use of: coffee (>10 units per day), alcohol (>5 units per day); 14. Recent use (within four weeks) of cannabis or any other non-prescription psychopharmaca, except St John’s Wort, or unwillingness to abstain from these substances during the study; 15. MR incompatible implants in the body (such as ear prothesis, insulin pump, or other metal implants); 16. Any risk of having metal particles in the eye, due to manual work without proper eye protections; 17. Tattoos containing red pigments; 18. (Suspected) pregnancy; if the patient is in doubt a pregnancy test is performed; 19. Claustrophobia; 20. The refusal to be informed of structural brain abnormalities that could be detected during the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale 17 point version. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NEO-FFI, neuroticism; 2. ‘Treatment expectancy’ - VAS; 3. DM-TRD; 4. IDS-SR; 5. BAI; 6. EQ-5D; 7. Wais Digit Symbol Substitution; 8. TiC-P; 9. Smoking: # smoked cigarettes per day and Fagerstrom test for nicotine dependence; 10. Exit interview; 11. MRI; 12. HR and HRV; 13. BDNF concentration in serum and plasma. 14. a urine sample in week -1, 5 and 10. | — |
Contacts
Public ContactR. Kortekaas
Postbus 196
Outcome results
None listed