Major Depressive Disorder Depression
Conditions
Interventions
Treatment will consist of 30 rTMS sessions in an 8-week period. The rMT will be defined in each participant during the baseline assessment. Treatment will target the left dorsolateral prefrontal corte
=0.9 the level of the dual n-back is increased, to for instance n=3. If the score of the patient is <
=0.9 the n-back level is lowered. One block consists of 20+n trials, each trial has a duration of 3000 ms. The visual spatial stimuli consist of blue squares projected on a computer screen at 9 differ
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age 18 years and older - Current depressive episode with moderate or severe depression (HDRS-17 >16) - Indicated for treatment with rTMS, i.e. inadequate response to >=2 adequate treatment trials - Ability to perform CCT task - Stable treatment for at least 6 weeks
Exclusion criteria
Exclusion criteria: - Lifetime diagnosis of bipolar disorder, schizophrenia or schizoaffective disorder - Current psychotic depressive episode - Meeting criteria of stimulant use disorder in the last 6 months or opioid use disorder in the last 12 months - Organic brain syndrome - Substance*induced psychiatric conditions or substance-related medical conditions (e.g. delirium tremens) - Presence of a concurrent significant medical condition impeding the ability to participate - Seizure disorders - Serious head trauma or brain surgery - Large or ferromagnetic parts in the head (except for a dental wire) - Implanted neurostimulator - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of rTMS augmented with a CCT task as opposed to rTMS combined with a placebo task, as assessed by clinician-rated change in depressive symptom severity measured with the HDRS-17. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness of rTMS + CCT versus rTMS + placebo task. Response, defined as >50% reduction in score on the HDRS-17. Remission, defined as HDRS-17 <8. Clinician-rated change in depressive symptom severity, assessed by change in HDRS-17 score over time during follow-up. Subjective assessment of change in depression symptoms with the self-rated version of the IDS (IDS-SR) after 8 weeks of treatment and during follow-up. Recurrence of depressive symptoms, assessed by change in remitter status between end of treatment and follow-up measurements. Change in performance on the Emotional Stroop and Robot Madness task between baseline and end of treatment. | — |
Countries
Belgium, Netherlands
Contacts
Public ContactA.I. Dalhuisen
Radboud Universitair Medisch Centrum
Outcome results
None listed