Efficacy of repetitive transcranial magnetic stimulation in patients with medication-resistant bipolar depression. A multicenter, randomized, double-blind, sham-controlled study
- Conditions
- bipolar depressionbipolar disorder10026753
- Registration Number
- NL-OMON50802
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 166
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.
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary clinical outcome is determined by testing the treatment effect on the<br /><br>course of depression severity, measured by the Structured Interview Guide for<br /><br>the Hamilton Depression Rating Scale with Atypical Depression Supplement<br /><br>(SIGH-ADS) during 5 weeks of active or sham rTMS. </p><br>
- Secondary Outcome Measures
Name Time Method