Transcranial magnetic stimulation in the treatment of bipolar depressio

Phase 3

Completed

• Conditions: 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

• Registration Number: ISRCTN77188420
• Lead Sponsor: ational Institute of Mental Health

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38785073/ (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-01-30
• Study Start: 2022-05-27
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified