Major Depressive Disorder, MDD, Depression, Suicidal Ideation, Suicidality, treatment-resistant depression Major Depressive Disorder, MDD, Depression, Suicidal Ideation, Suicidality, treatment-resistant depression
Conditions
Interventions
During baseline period, every participant will get two sessions of CBT per week combined with 2 doses of sham rTMS per CBT session. Every CBT session starts with 1 dose of sham rTMS during the first 1
The intervention phase will continue immediately after baseline and consists of 10 weeks where the participant will receive 40 doses of active rTMS (10Hz DASH protocol, 120% MT, L-DLPFC, >
3000 pulses, localisation through BEAM F3) combined with 20 CBT sessions. CBT will stay the same over both TMS-conditions and will consist of at least, but not limited to, cognitive restructuring and
Sponsors
GGZ Oost Brabant
Eligibility
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: Adolescents aged between 12 and 18 years in care for depression at a mental health care facility in the Netherlands.DSM-5 diagnosis of depression, confirmed with the MDD part of the Mini International Neuropsychiatric Interview – Simplified (MINI-S), Dutch version 1.1. for DSM-5 (Overbeek et al., 2019). Severe depression verified by a score > 19 on the BDI II (Beck et al., 1996), defined as moderate to severe depression.Participant received two prior ineffective treatments for depression, which is at least one psychological and one biological intervention.In the case of suicidal ideation: the participant is in possession of an up-to-date safety plan not older than a month when entering the study. Participant is to give written informed consent.If the participant is under 16 years old, the parents are to give additional written consent. Proficient use of Dutch language.
Exclusion criteria
Exclusion criteria: The depressive disorder has psychotic features or is induced by drugs.A history of one or more psychotic or manic episodes.Substance use disorder.Contraindications in current rTMS guidelines (Epilepsy or other neurological conditions, intracranial metallic or magnetic pieces, pacemaker, cochlear implant, pregnancy (Lefaucheur et al., 2020; Rossi et al., 2021)).There is acute suicide risk with an indication for hospitalization. Acute suicide risk is defined as a situation where the patient is in danger because of its suicidality. The patient is excluded from the study when according to the Dutch Multidisciplinary Guideline for Diagnosing and Treating Suicidality (Verweij et al., 2013) an admission to the crisis unit is indicated and/or when the primary focus of treatment is placed on treating the suicidality instead of the depressive symptoms. This is operationalized via the standard, guideline-based procedure of care at the treating facility in case of suicidality: by the CASE-approach (Chronological Assessment of Suicide Events; Shea, 1998) and establishing a structural diagnosis of the suicidality.Previous treatment with TMS or ECT. Absence of parental consent for participants under 16.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is severity of depressive symptomatology as measured with the PHQ-A on a daily basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Further assessment of depressive symptomatology will be done with the BDI, MADRS CDI 2:P at eight time points: at the beginning, the 5th session and end of baseline, every 5th session within intervention (CBT session 5, session 10, session 15, session 20) and during follow ups (3 months and 6 months). The participant will formulate a personal goal related to their depressive symptoms, which will be assessed on a daily basis. Secondary study parameters include remission of depression, as well as response and remission in suicidal ideation (measured with the SIDAS). Additional analyses will explore differential trajectories of remission in depression and suicidal ideation and will explore specific depressive symptoms that may predict rTMS treatment outcomes and the influence of adolescent and parental expectations on treatment response. | — |
Countries
Netherlands
Contacts
Public ContactMLAJ Silvertand
GGZ Oost Brabant
Outcome results
None listed