Bipolar I or II disorder, current episode depressive, moderate to severe, without psychotic symptoms Mental and Behavioural Disorders Bipolar affective disorder, current episode mild or moderate depression, Bipolar affective disorder, current episode severe depression without psychotic symptoms
Conditions
Interventions
Patients are randomly allocated according to permuted block design with a fixed block size of 6 to one of the three intervention groups:
1. Active 10 Hz rTMS applied to the left dorsolateral prefronta
1200 pulses per session
20 sessions
2. Active 10 Hz rTMS applied to the right ventrolateral prefrontal cortex (VLPFC) (BA 47), 100% of motor threshold, 2 s on, 8 s off, 10 minutes duration
20 sessions
3. Sham rTMS with a sham coil applied either to left DLFPC or to right VLPFC (randomly per ten subjects)
20 sessions
Sponsors
National Institute of Mental Health
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Both inpatients and outpatients with bipolar disorder I and II, currently in the major depressive episode (BDE) diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria 2. Females or males 3. Age 18 to 70 years 4. Moderate to severe depression based on the Montgomery-Åsberg Depression Rating Scale (MADRS) score =20 5. Current BDE lasting at least 4 weeks but no more than 12 months 6. Taking mood stabilizers (lithium, valproate, lamotrigine) or second-generation antipsychotics (aripiprazole, olanzapine, quetiapine, risperidone) at a steady dosage for at least 4 weeks before screening and it is clinically appropriate to continue during the trial period 7. Failed to respond to at least one adequate antidepressant trial in the current BDE 8. Being able and willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Psychotic symptoms during the current BDE 2. Hypomanic, manic, or mixed features at screening or at the baseline visit (the Young Mania Rating Scale (YMRS) >11) 3. Significant risk of suicidal behavior based upon MINI or MADRS item 10 (suicidal thoughts) =4 at screening or baseline visit 4. Eight or more episodes of BD within 12 months prior to study enrollment 5. History of any DSM-IV Axis I diagnosis other than bipolar disorder I and II, with exception of anxiety disorders 6. History of substance use disorders (except nicotine addiction) in the last year 7. Personality disorder that makes participation in the trial difficult in the opinion of the investigator 8. Pregnancy or breastfeeding 9. Contraindication for rTMS therapy or MRI scanning (history of epilepsy or any medical condition likely to increase risk of seizure, mass brain lesions, cerebrovascular accident, a history of major head trauma with unconsciousness, metal implants or fragments in the head, pacemaker, or other electronic devices) 10. Electroconvulsive therapy within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity is measured using the Montgomery–Åsberg Depression Rating Scale (MADRS) from baseline to week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression severity is measured using the Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) and overal psychopathology related to bipolar disorder is measured using the Clinical Global Impression-Bipolar (CGI-BP) scores from baseline to week 4 2. Response and remission rates, as defined by a 50% or greater reduction in MADRS total scores and as a score of 10 or less in the MADRS total scores at the end of treatment 3. Dropout rates and adverse events rates measured using the Adverse Effects Questionnaire at weeks 1, 2, 3, and 4 | — |
Countries
Czech Republic
Contacts
Public ContactTomas Novak
Outcome results
None listed