bipolar depression bipolar disorder Bipolar depression, bipolar disorder
Conditions
Interventions
Adults with current bipolar depression who meet the inclusion criteria will
receive 25 rTMS sessions once daily five times a week, for five weeks, in
adjunction to ongoing treatment as usual. If pat
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Eligibility criteria: - 18 years or older of age; - Sufficient level of spoken and written Dutch; - Ability to freely provide written informed consent; - patients with bipolar I or Il disorder, who have a medication-resistant bipolar depression, i.e., lack of remission for eight consecutive weeks after two different adequate medication trials with at least two recommended monotherapy treatments or at least one monotherapy treatment and another combination - A score > 16 points on the Hamilton depression rating scale for atypical depression (SIGH-ADS). - A current DSM-5 diagnosis of bipolar depression, ascertained by the Mini International Neuropsychiatry Interview (MINI-plus). - Or have tried at least two monotherapies in the previous depressive episode, which must have occurred within 12 months previous of the present episode but not more than three depressive episodes within these 12 months. - Stable medication 4 weeks prior to study, including anti-manic medication, consisting of lithium, valproate, carbamazepine and all anti-psychotic drugs, in patients with bipolar I disorder. Patients with a bipolar 2 disorder using anti-depressant medication will also need to use anti-manic medication. 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.
Exclusion criteria
Exclusion criteria: Partcipants meeting any of the following criteria will be excluded from participation in this study: - A (hypo)manic episode within 3 months before the start of the trial. - A Young Mania Rating Scale score > 12, before the start of the trial. - Current psychotic disorder, including psychotic depression, assessed at the baseline interview. - Dementia, assessed with a dementia screening tool, i.e. the Montreal Cognitive Assessment (34), assessed at the baseline interview. - 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?". - Metallic devices implanted above the neck, assessed at the baseline interview. - Patients diagnosed with epilepsy, by a neurologist, assessed at the baseline interview. - Patients with bipolar Il disorder who use anti-depressant medication without anti-manic medication or patients with bipolar I disorder, not using anti-manic medication. - 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. - Pregnancy, If there is any doubt a pregnancy test is performed, at baseline. - Known with rapid cycling.; e.g. more than 3 mood cycles per year. - Inability to understand or comply with study requirements as judged by the investigators, assessed at the baseline interview. - Earlier experiences with rTMS (as treatment or in a study)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical outcome is determined by testing the treatment effect on the course of depression severity, measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement (SIGH-ADS) during 5 weeks of active or sham rTMS. | — |
Secondary
| Measure | Time frame |
|---|---|
| a) Economic evaluation based on the general principles of a cost-effectiveness (utility) analysis, which will be performed alongside the intervention by comparing patients treated with active rTMS with those receiving sham rTMS. Patient-reported outcome measures (i.e., quality-adjusted life years) will be determined. Additionally, societal costs and health consumption will be assessed for the economic evaluation at baseline and 12 weeks post-treatment. b) Response rate defined as 50% reduction of depressive symptoms, based on the SIGH ADS, directly after 25 active or sham rTMS sessions. c) Remission rates directly after 25 active or sham rTMS sessions. Remission is defined as a Hamilton score (derived from the SIGH ADS) of 8 and lower. d) The sustained response rate, i.e., those participants, who at 4 weeks and 12 weeks post-treatment, maintain a 50% reduction of depressive symptoms. e) The sustained response rate after 21 weeks post-treatment (in real rTMS group). f) Prevalence of side effects, including a possible switch to mania g) Description of facilitators and barriers with regard to implementation. h) Changes in negative and positive affect. Presence of negative mood (depressed mood) and anhedonia (lack of interest and pleasure) are considered core symptoms of depression, while absence of positive mood is not taken into account in questionnaires on assessing the severity of depression. The Leuven Affect and Pleasure Scale (LAPS) provides the opportunity to not only study changes in depressed mood, but also assesses changes in positive affect. Other outcome parameters: We want to explore the possible effects of different patient characteristics, determined at baseline, on outcome of treatment in patients treated with rTMS. The following demographic and clinical factors, that have been studied in relation to the course of bipolar depression, have not been studied in relation to outcome in patients treated with rTMS: type of bipolar di | — |
Countries
Netherlands
Contacts
Public ContactE Exel
Amsterdam UMC
Outcome results
None listed