Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545474
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Effects of rTMS Compared to SSRI as Early Treatment of Depression Early-TMS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation rTMS as an Early Intervention in Major Depression MD Compared to Antidepressant Selective Serotonin Reuptake Inhibitor SSRI Medication Early-TMS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Early-TMS
Brief Summary:
The aim of this randomized multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression In this two-stage therapy response-adapted trial 106 patients suffering from non-treatment resistant major depression non-TR MD will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation TBS or 4 weeks antidepressant SSRI medication The allocation to Stage II occurs therapy response-adapted Patients receive either a maintenance treatment or a switch to the respective other treatment arm The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale MADRS after 4 weeks at the end of Stage I
Detailed Description:
This is a therapy response-adapted two-phase randomized and controlled study Initially the study participants will be randomized to two treatment arms Stage I 4 weeks TBS vs SSRI After completion of Stage I the allocation to Stage II 4 weeks occurs therapy response-adapted The type of further treatment depends on whether a remission a treatment response or non-response has occurred in Stage I If remission has been achieved the treatment form already applied is continued as maintenance therapy In the case of non-response a switch to the other treatment arm takes place For patients who show a treatment response but have not achieved remission the corresponding patient preference is given special consideration for Stage II and thus determines the type of further treatment Depending on patient preference it is therefore possible both to continue treatment from Stage I and to switch to the other treatment arm
The study aims to answer the question of whether a 4-week bilateral TBS is not inferior to standard antidepressant treatment with an SSRI in drug-naïve patients with MD in terms of efficacy and tolerability
The study aims to answer the question of whether a 4-week bilateral TBS is not inferior to standard antidepressant treatment with an SSRI in drug-naïve patients with MD in terms of efficacy and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None