Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 55
Healthy Volunteers: t
View:

• 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.

• a. 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.

Locations
United States
Massachusetts
Martinos Center for Biomedical Imaging
RECRUITING
Charlestown
Contact Information
Primary
Alexis Worthley, BA
er-studies@mgh.harvard.edu
6177248780
Backup
Blake Andreou, BA
er-studies@mgh.harvard.edu
6177248780
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 60
Treatments
No_intervention: Healthy Control
This group consists of individuals with no psychiatric diagnosis.
Experimental: Bipolar Group
This group consists of individuals with a diagnosis of bipolar disorder who have been randomized to receive high-dose TMS (i.e., 1800 pulses) and sham TMS.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov