Can this effect be utilised clinically, especially in patients with major depressive disorder?
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
17-point version of the 'Hamilton Depression Rating Scale' (HAMD17)
Secondary outcome
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
Background summary
According to the literature, exposure to weak pulsating magnetic fields has a
potential antidepressive effect on experimental animals and human subjects.
Study objective
Can this effect be utilised clinically, especially in patients with major
depressive disorder?
Study design
Intervention study, double blind,completely placebo controlled randomised
parallel design.
Intervention
A head cap with small electromagnets is placed on the head. Magnetic fields
with flux densities of <5 mT are applied to the head.
Study burden and risks
Patients visit the treatment room for five weeks. Daily visits on working days
lasting one hour each. Therefore in total it takes 25 hours in the treatment
room.
The treatment itself might be experienced as boring by the patients, because
they have to sit still for 30 minutes.
Reading is allowed to alleviate this.
No adverse events or risks due to the intervention are expected.
There are two MRI sessions: one at baseline and one after five weeks. Each
session lasts for no longer than 60 minutes. During the scans patients lie in
the MRscanner, which is a narrow space and are required to lie still. During
certain periods they perform tasks.
The questionnaires constitute a negligible to mild burden.
Three venapunctions.
Three urine samples.
No switching of antidepressant medication is allowed during the study.
No other behaviours are enforced or prohibited. Patients may continue their
normal medication and/or psychotherapy.
A. Deusinglaan 2
Groningen 9700 AD
NL
A. Deusinglaan 2
Groningen 9700 AD
NL
Listed location countries
Age
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
• 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
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL39450.042.12 |
| Other | NTR12336 |