Dutch-Depression Outcome trial comparing 5 day multi daily neuronavigated Theta burst sessions with 6 weeks standard rTMS
- Conditions
- depressionmood disorder10027946
- Registration Number
- NL-OMON56337
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 108
Adult patients with unipolar depression who did not respond to two or more
evidence-based treatments for depression, in the current depressive episode,
aged 18 years and over. In order to be eligible to participate in this study, a
participant must meet all following criteria: - 18 years of age or older; -
Sufficient level of spoken and written Dutch; - Ability to freely provide
written informed consent; - Current DSM-5 diagnosis of a depressive episode,
ascertained by the Mini International Neuropsychiatry Interview (MINI-S). - A
Hamilton depression rating score (HDRS) of >16 points - have a treatment
resistant depression, defined according to the criteria of Conway, that is,
lack of remission for eight consecutive weeks after two different
evidence-based treatments anti-depressant medication has to be adequately
dosed. - Stable anti-depressant medication 6 weeks prior to study.
Benzodiazepines may be used up to a dosage equivalent of 3.0 mg lorazepam, and
can be lowered over time during the study based on clinical judgement.
Participants meeting any of the following criteria will be excluded from
participation in this study - Bipolar disorder. - Current psychotic disorder*
including psychotic depression, assessed by treating psychiatrist. - Suspected
dementia, assessed with a dementia screening tool, i.e.i.e., the Montreal
Cognitive Assessment (MOCA)(31), with a score of less than 20 points, or a
clinical suspicion of dementia, or neuroimaging indication for
neurodegeneration with a Fazekas > 1 and MTA >1. These cut-offs ensure
exclusion of patients with (preclinical) dementia. - 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.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?* (32). - Metallic devices implanted above the neck,
assessed at the baseline interview. - Patients diagnosed with epilepsy, by a
neurologist, assessed at the baseline interview. - 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. -
Inability to understand or comply with study requirements as judged by the
investigators, assessed at the baseline interview. - Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Clinical outcome is remission, which is defined as a score of 7 or lower on the<br /><br>clinician-rated HDRS-17 (Hamilton Depression rating Scale) measured directly<br /><br>after the last treatment session.</p><br>
- Secondary Outcome Measures
Name Time Method