BRIGhTMIND: brain imaging guided transcranial magnetic stimulation in depressio
- Conditions
- DepressionMental and Behavioural Disorders
- Registration Number
- ISRCTN19674644
- Lead Sponsor
- ottinghamshire Healthcare NHS Foundation Trust
- Brief Summary
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342821/ protocol (added 18/09/2020) 2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/35049517/ Magnetic Resonance Imaging Protocol and SARS-CoV-2-Induced Changes (added 21/01/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38228914/ (added 22/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 255
Current inclusion criteria as of 13/10/2021:
1. Adults >18 years
2. Diagnosis of MDD (defined according to DSM-5) that is treatment resistant (defined as scoring 2 or more (42) on the Massachusetts General Hospital Treatment Resistant Depression staging score (51) See appendix on more detailed scoring of treatment resistance
3. HDRS-17 score of 16 or more (moderate to severe depression) (52)
4. Capacity to provide informed consent before any trial-related activities
Previous inclusion criteria:
1. Adults >18 years
2. Diagnosis of MDD (defined according to DSM-5) that is treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Treatment Resistant Depression staging score)
3. Capacity to provide informed consent before any trial-related activities
Current exclusion criteria as of 02/07/2019:
History of bipolar disorder (due to risk of mania) or depression secondary to other mental disorder
2. Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
3. Standard contraindications to MRI i.e. irremovable metal objects in and around body e.g. cardiac pacemaker, implanted medication pump and pregnancy (any doubt resolved by pregnancy test, women of childbearing age taking precautions against pregnancy) This will include other potential complicated factors such as red tattoo’s which consist of iron on the head, neck and back and claustrophobia (we offer mock scanner testing and training in some sites)
4. Major unstable medical illness requiring further investigation or treatment.
5. Change in prescribed medication 2 weeks before baseline assessment.
6. Prescription of lamotrigine, gabapentin, pregabalin in the 2 weeks prior to baseline assessment.
7. Daily prescription of benzodiazepine above 5 mg diazepam equivalents, zopiclone above 7.5 mg, zolpidem above 10 mg or zaleplon above 10 mg. These
drugs should not be used intermittently in the 2 weeks before baseline assessment.
8. Current substance abuse or dependence defined by DSM-5 criteria)
9. Prior TMS treatment.
10. At risk of suicidality.
11. Potential complicated factors relating to the TMS treatment i.e. hairstyles which would impair magnetic transmission and piercings. (Participants would only be excluded if they chose to not make the changes required to ensure effective treatment.)
12. Involved with any other clinical trial at the time of consent or 6 months prior.
13. Unable to read or understand English.
Previous exclusion criteria:
1. History of bipolar disorder (due to risk of mania) or depression secondary to other mental disorder
2. Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery
3. Standard contradictions to MRI i.e. irremovable metal objects in and around body e.g. cardiac pacemaker, implanted medication pump and pregnancy (any doubt resolved by pregnancy test, women of childbearing age taking precautions against pregnancy). This will include other potential complicated factors such as red tattoos which consist of iron on the head, neck and back and claustrophobia (we offer mock scanner testing and training in some sites)
4. Major unstable medical illness requiring further investigation or treatment
5. Change in prescribed medication in the 2 weeks preceding the start of TMS trial or prescription of lamotrigine, pregabalin, gabapentin or benzodiazepines that act on brain glutamate or GABA (only occasional use of other hypnotic drugs zopiclone, zolpidem, zoleplon and promethazine will be allowed)
6. Current substance abuse or dependence (defined by DSM-5 criteria)
7. Prior TMS treatment
8. At risk of suicidality
9. Potential complicated factors relating to the TMS treatment i.e hairstyles which would impair magnetic transmission and piercings (participants would only be excluded if they chose to not make the changes required to ensure effective treatment)
10. Involved with any other clinical trial at the time of consent or 6 months prior
11. Unable to read or understand English
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measure as of 13/10/2021:<br>The efficacy of cgiTBS compared with standard rTMS measured using the Hamilton Depression Rating Scale (HDRS-17) at baseline, 8, 16 and 26 weeks post randomisation date<br><br>Previous primary outcome measure:<br>The efficacy of cgiTBS at 16 weeks (primary clinical outcome, 50% drop in HDRS-17 score from baseline to 16 weeks) and 26 weeks compared with standard rTMS; in people with TRD ; Timepoint(s): 16 and 26 weeks post randomisation
- Secondary Outcome Measures
Name Time Method