Plain English Summary
Background and study aims
Depression is very common disease which affects one in five people in their lifetime and is associated with a large burden for patients and their caregivers. It can cause symptoms of unhappiness, hopelessness, anxiety, tiredness, and low mood. One in three patients will not benefit from first line treatments such as medication and psychotherapy (talking to a therapist), and may suffer from a chronic depression. Repetitive magnetic stimulation (rTMS) is a relative new treatment for depression that uses magnetic pulses to activate superficial areas (near the surface) in the brain that are underactive in depression. The aim of this study is to evaluate the use of rTMS as a treatment for chronic, treatment-resistant depression.
Who can participate?
Adults aged 18 and older who have major depressive disorder.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive 20 rTMS sessions over a period of four weeks. Those in the second group receive 20 sham sessions. Participants are measured at the beginning of the study and after every week of stimulation to evaluate their resting motor threshold. Depressive symptoms are measured before and after treatment to see how effective the treatment is at treating depression.
What are the possible benefits and risks of participating?
Participants may benefit from a better mood and relief of depression after the treatment. An incidental epileptic seizure is a rare complication, but has no further consequences.
Where is the study run from?
Radboud University Nijmegen Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
November 2012 to November 2019
Who is funding the study?
Radboud University Nijmegen Medical Centre (Netherlands)
Who is the main contact?
Dr Philip van Eijndhoven
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL42420.091.12
Study information
Scientific title
lnvestigating the role of rTMS in the treatment of chronic depression
Acronym
DREAMS
Study hypothesis
High frequent repetitive transcranial magnetic stimulation (10 Hz rTMS) over the left prefrontal cortex is superior than placebo in the treatment of chronic, treatment-resistant depression.
Ethics approval
Ethics Committee CMO regio Arnhem-Nijmegen, 14/03/2013, ref: 2012/498
Study design
Longitudinal randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Depression
Intervention
Patients were randomly assigned to one of two groups using block randomisation. Both investigators and patients are blinded (double blind study); the physicians and nurses who treat the patients are not blinded.
Intervention group: Participants receive 20 rTMS sessions (10Hz stimulation of left DLPFC) over a period of 4 weeks. This involves 5 sessions of approximately 30 minutes, per week. Magstim Rapid 2 TMS is used with a focal, 8-figure shaped 70mm coil. At the beginning of the study and after every week of stimulation, the resting motor threshold (resting MT) is measured of the right abductor pollicis brevis muscle. Treatment intensity was standardized at 110% of the resting MT.
Control group: Participants receive 20 sham sessions of equal duration in which the coil is tilted 45 degrees away from the scalp, making the stimulation site outside the skull. At the beginning of the study and after every week of stimulation, the resting motor threshold (resting MT) is measured of the right abductor pollicis brevis muscle.
After each session there there is a debriefing and each week there is an evaluation of treatments effect. A week after the last session participants hear if they had the real or placebo treatment. In case of placebo treatment, participants can then chose to undergo the real rTMS treatment. Participants are assessed one week after treatment for their depressive symptoms.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Depressive symptoms are measured using the Hamilton Depression Rating Scale at baseline and one week after treatment end.
Secondary outcome measures
1. Response as defined as a ≥50% decrease of the HDRS score between baseline and one week after treatment end
2. Remission, as defined as a HDRS score ≤7, is assessed one week after the last rTMS treatment
3. Side-effects are assessed using a side-effect questionnaire at baseline and one week after treatment end
4. Neurobiological changes related to rTMS treatment are measured using a combined EEG/FMRI longitudinal set-up at baseline and one week after treatment end
Overall trial start date
01/11/2012
Overall trial end date
01/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males and females above 18 years of age
2. Unipolar major depressive disorder without psychotic symptoms (DSMlV), with a chronic course during the last two years
3. Treatment resistance for at least two antidepressants treatment and a form of psychotherapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Total final enrolment
31
Participant exclusion criteria
1. Presence of a current or past relevant somatic or neurological disorder
2. A comorbid diagnosis of bipolar disorder, schizophrenia or substance dependence disorders
3. Epilepsy, convulsion or seizure (TMS)
4. Serious head trauma or brain surgery
5. Large or ferromagnetic metal parts in the head (except for a dental wire)
6. lmplanted cardiac pacemaker or neurostimulator
7. Pregnancy
Recruitment start date
01/07/2013
Recruitment end date
01/07/2018
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Centre
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre
Sponsor details
Department of Psychiatry
Geert Grooteplein Zuid 10
Nijmegen
6525 GA
Netherlands
+31 243 613 489
Aart.Schene@radboudumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud University Nijmegen Medical Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Philip.vaneijndhoven@radboudumc.nl
Intention to publish date
31/07/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2020 results in https://pubmed.ncbi.nlm.nih.gov/32385741 (added 11/05/2020)