NL-OMON50802
Not yet recruiting
Phase 4
Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study - T-Bide
Amsterdam UMC0 sites166 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- bipolar depression
- Sponsor
- Amsterdam UMC
- Enrollment
- 166
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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