MDD
Conditions
Keywords
TMS, Brain Networks, Symptom Networks
Brief summary
This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment. Additionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment. Patients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.
Interventions
None listed
Sponsors
Goethe University
University of Giessen
Philipps Universität Marburg
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation. * Men and women will be included in a balanced ratio. * German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.
Exclusion criteria
* Patients younger than 18 or older than 70 will be excluded * Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Post TMS Treatment Effect Measured by HAMD | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Hamilton Depression Rating Scale (HAMD). HAMD: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with 17 and 4 additional items (duration approx. 20 min). For this outcome measure, the first 17 items are used to calculate a sum score for interpretation, because cut-off scores exist for the HAMD-17 version. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 52. A sum score ≤ 8 indicates no depression. A sum score between 9-16 indicates mild depression. A sum score between 17-24 indicates moderate depression. A sum score ≥ 25 indicates severe depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre-Post TMS Treatment Effect Measured by MADRS | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Montgomery-Asberg Depression Rating Scale (MADRS). MADRS: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with higher sensitivity to change than the HAMD with 10 items (duration approx. 15 min). Higher scores reflect greater symptom intensity. A sum score of the 10 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60. A sum score ≤ 6 indicates no depression. A sum score between 7-16 indicates mild depression. A sum score between 20-34 indicates moderate depression. A sum score ≥ 35 indicates severe depression. |
| Pre-Post TMS Treatment Effect Measured by IDS-C | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Inventory of Depressive Symptomatology Clinician Rated (IDS-C). IDS-C: Standard interview for assessing current depressive symptoms with higher sensitivity to residual symptoms than the HAMD with 30 items. The sum score for interpretation is calculated using 28 of the 30 items. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 84. A sum score ≤ 13 indicates no depression. A sum score between 14-25 indicates mild depression. A sum score between 26-38 indicates moderate depression. A sum score ≥ 48 indicates severe depression. |
| Pre-Post TMS Treatment Effect Measured by HAMA | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Hamilton Anxiety Rating Scale (HAMA). HAMA: Standard interview to assess the severity of anxiety symptoms (duration approx. 5 min). Higher scores reflect greater symptom severity. A sum score of the 14 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 56. A sum score ≤ 17 indicates mild severity. A sum score between 18-24 indicates mild severity. A sum score between 25-30 indicates moderate to severe. A sum score ≥ 31 indicates severe to very severe. |
| Pre-Post TMS Treatment Effect Measured by YMRS | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Young Mania Rating Scale (YMRS). YMRS: Standard interview for assessing manic symptoms (duration approx. 10 min). Higher scores reflect greater symptom intensity. A sum score of the 11 items is calculated for interpretation: The sum scores range between a minimum of 0 and a maximum of 60. A sum score ≤ 12 indicates no or minimal manic symptoms. A sum score between 13-19 indicates mild mania or hypomania. A sum score between 20-25 indicates moderate mania. A sum score ≥ 26 indicates severe mania. |
| Pre-Post TMS Treatment Effect Measured by BDI-II | Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks) | Difference Score between pre-TMS and post-TMS on the Beck Depression Inventory Version 2 (BDI-II). BDI-II: Standard self-report questionnaire for assessing the severity of current depressive symptoms (duration approx. 4 min). Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 63. A sum score of the 21 items is calculated for interpretation: A sum score ≤ 13 indicates no or minimal depression. A sum score between 14-19 indicates mild depression. A sum score between 20-28 indicates moderate depression. A sum score ≥ 29 indicates severe depression. |
| Patient and Clinician expected treatment outcome | pre-TMS treatment | PATHEV questionnaire for patients once before treatment. Expectancy questionnaire for clinician on treatment effect for the patient. Scores on three sub-scales of the Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV). PATHEV: Standard questionnaire to evaluate treatment effect expectations (duration approx 3 min). Higher scores on the sub-scales indicate hope of improvement, fear of change and treatment fit. The sub-scales consist of 4, 3 and 4 items. The sum scores range between a minimum of 11 and a maximum of 55. |
Countries
Germany
Contacts
CONTACTJonathan Repple, Prof. Dr. med.
Outcome results
None listed