Efficacy of repetitive Transcranial magnetic stimulation in patients with medication-resistant BIpolar DEpression: a multicenter, randomized, double-blind, sham-controlled study

Amsterdam UMC Location VUmc0 sites166 target enrollmentJanuary 31, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 31, 2022

End Date

February 1, 2025

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

Amsterdam UMC Location VUmc

•1\. 18 years of age or older
•2\. Sufficient level of spoken and written Dutch
•3\. Ability to freely provide written informed consent
•4\. Current DSM\-5 diagnosis of a depressive episode in bipolar I or II disorder, ascertained by the Mini International Neuropsychiatry Interview (MINI\-plus)
•5\. A Hamilton depression rating score (HDRS) of \>16 points: this score will be obtained from the SIGH\-ADS, a depression rating scale able to determine the HDRS score and a score for atypical depression
•6\. Have a medication\-resistant bipolar depression, defined according to the criteria of Hidalgo\-Mazzei, that is, lack of remission for 8 consecutive weeks after two different medication trials, at adequate therapeutic doses, with at least two recommended monotherapy treatments or at least one monotherapy treatment and another combination
•7\. Stable medication 4 weeks prior to the study, including anti\-manic medication, consisting of lithium, valproate, carbamazepine and all anti\-psychotic drugs, in patients with bipolar I disorder. Dosages of anti\-manic medications will be determined between the participant/patient and his/her psychiatrist. Stable medication also includes stable use of benzodiazepines up to a dosage equivalent of 3\.0 mg lorazepam

•1\. A (hypo)manic episode within 3 months before the start of the trial
•2\. A Young Mania Rating Scale score \>12, before the start of the trial
•3\. Current psychotic disorder including psychotic depression, assessed by treating psychiatrist
•4\. Dementia, assessed with a dementia screening tool, i.e. the Montreal Cognitive Assessment (MOCA), assessed at the baseline interview. Scoring below 20 points is an indication of the presence of dementia, this score below 20 points will be used as an exclusion criterium
•5\. Active suicidal thoughts and intent to act on it, assessed at the baseline interview and before the start of the trial. This assessment is based on the Columbia suicide severity rating scale, i.e. question 5 is answered positive Have you started to work out or worked out the details of how to kill yourself? Do you intend to carry out this plan?”
•6\. Metallic devices implanted above the neck, assessed at the baseline interview
•7\. Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline interview
•8\. Patients with bipolar II disorder who use anti\-depressant medication without anti\-manic medication or patients with bipolar I disorder, not using anti\-manic medication
•9\. Substance abuse 4 weeks prior to the study, including high dosage of benzodiazepine, a dosage equivalent higher than 3\.0 mg lorazepam, assessed at the baseline interview
•10\. Pregnancy, if there is any doubt a pregnancy test is performed at baseline