NCT04284267Completed
Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 56 (actual)
- First submitted
- 20 Feb 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 30 Oct 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT04284267
What you commit to
- Study type: Interventional
- Participants enrolled: 56
- From 1 Mar 2021 to the primary completion date, 30 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma.
- Presence of metallic implants that would interfere with safety during fMRI scanning.
- Medication instability (\<3 months).
- Neurologic disorder, prior neurosurgical procedure, prior ECT or TMS, history of seizures or head trauma.
- Presence of metallic implants that would interfere with safety during fMRI scanning.
Other illness
- Current or history of psychiatric disorders
- Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol); schizophrenia; delusional disorder; and psychotic disorders.
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol), verified by urine toxicology screen; schizophrenia; delusional disorder; and psychotic disorders.
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
Other
- Endorsement of clinical levels of emotion dysregulation
- Current pregnancy.
- Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10).
- Current pregnancy.
Who the study is looking for
- Male or female age 18-55
- No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI).
- Non-Clinical Levels of Emotion Dysregulation, as assessed using the Difficulties in Emotion Regulation Scale (DERS) Non-clinical levels of emotion dysregulation will be defined as a score \< 80 on the DERS.
- Male or female age 18-55
- Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI.
- Current mood state euthymic.
- Hamilton-Depression Rating Scale (HAM-D-17) and Young Mania Rating Scale (YMRS) will be used to assess current depressive and manic symptoms. Euthymia will be defined as a HAM-D-17 score \<10 and YMRS score \<12.
- Clinical Levels of Emotion Dysregulation, as assessed using the DERS. Clinical levels of emotion dysregulation will be defined as a score \> 80 on the DERS.
Age in the registry: 22 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Martinos Center for Biomedical Imaging Coordinator of this site? Confirm its status | Charlestown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.