depression major depressive disorder
Conditions
Interventions
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Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of MDD, first or recurrent major depressive episode (MDE), as established by MINI-Interview • Age range: 18-80 years • At least moderately severe depression (>17 on HAMD17) • • Not having responded (i.e. maintained in a MDE) to one antidepressant during the current episode, given for at least four weeks and in an adequate dose (i.e. the defined daily dose (DDD) (Ruhe et al 2012). • Good understanding of spoken and written Dutch • In-patient or out-patient
Exclusion criteria
Exclusion criteria: • Presence of a relevant neurological disorder such as dementia or epilepsy • Other relevant major psychiatric disorders such as a primary psychotic disorder or an antisocial or borderline personality disorder • Major depressive episode with psychotic features • Visual or hearing problems that cannot be corrected • Suicidal thoughts (>2 on HAMD17 for suicidal ideation) or a previous serious suicide attempt • Recent (past three months) alcohol or drug abuse or dependence • pregnancy, lactation • inability to comply with treatments and/or assessments. • Recent change (last four weeks) in antidepressant medication or requirement to change antidepressant medication during the course of the study. • 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 • Use of somatic medication that may affect mood within the last four weeks • Excessive use of: coffee (>10 units per day), alcohol (>5 units per day) • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 17-point version of the 'Hamilton Depression Rating Scale' (HAMD17) | — |
Secondary
| Measure | Time frame |
|---|---|
| NEO-FFI Questions relating to neuroticism are used. *Treatment expectancy* Verbal analogue scale (0 to 10) to indicate how effective the patient thinks the treatment will be. DM-TRD Questionnaire to measure treatment resistance. Exit interview Patient is asked if they think they received PEMF or placebo. MRI Magnetic resonance spectroscopy Resting state brain activity: fMRI. Reward induced brain activity: fMRI. HR and HRV BDNF concentration in serum Biomarkers in urine. IDS-SR Self-completed depression questionnaire. BAI Questionnaire for anxiety symptoms EQ-5D Questionnaire for health related quality of life. Wais Digit Symbol Substitution Questionnaire for health related quality of life. TiC-P Self-completed questionnaire to assess medical consumption. Smoking 1. # smoked cigarettes per day. 2. Fagerstrom test for nicotine dependence Gender, age, treatment resistance Medication Body weight | — |
Countries
Netherlands
Outcome results
None listed