Finding out if adjustment of intensity and duration of rTMS stimulation will produce a more robust antidepressant effect.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Percentage of change from baseline on the Hamilton Depression Rating Scale
(HAMD, 17 items)
2. Percentage of patients with clinical response (= 50 % reduction in HAMD
score)
3. Percentage of patients with partial clinical response (= 30 % reduction in
HAMD score)
Secondary outcome
Emotion Recognition Task
Background summary
Schutter et al. (2008) found a partial clinical effect on major depression by
stimulating the right parietal cortex with rTMS. It is supposed that adjustment
of intensity and duration of stimulation will produce a more robust
antidepressant effect.
Study objective
Finding out if adjustment of intensity and duration of rTMS stimulation will
produce a more robust antidepressant effect.
Study design
Randomized double-blind placebo controlled. Patients in the placebo condition
may, on request, receive real rTMS treatment after the follow up period.
Intervention
rTMS on the right parietal cortex
2 Hz with an inter-impuls interval of 0,5 sec.
at 110 % of motor threshold
15 sessions of 20 minutes during a period of three weeks
Study burden and risks
Stimulation over the scalp with a magnetic coil is painless. There are no known
side effects of rTMS stimulation other than a slight headache. Application of
the proposed stimulation parameters has proven to be safe, and not to provoke
epileptic seizures (lit. ...).
Postbus 9243
1006 AE Amsterdam
NL
Postbus 9243
1006 AE Amsterdam
NL
Listed location countries
Age
Inclusion criteria
age from 18 yrs onward
unipolar depressive disorder
only the following medication is allowed: SSRI's, venlafaxine, mirtazapine, antihistamanics for sedation
medication to be kept constant during the trial
Exclusion criteria
bipolar disorder, dysthymic disorder
suicidality
Use of beta-blockers, other antidepressants or psychotropic medication, thyroid hormone, benzodiazepines, anti-epileptics
history of epilepsy or epileptic abnormalities on EEG
intracranial metal, pacemaker
schizophrenia, addiction, mental handicap, not speaking Dutch
lefthandedness
Design
Recruitment
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 | NL26903.029.09 |