Bipolar Disorder, NOS Clinical Trial
Official title:
Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS
| NCT number | NCT02435225 |
| Other study ID # | MH10126001 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | September 2017 |
| Verified date | July 2018 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The investigators propose to study 30 adolescents with bipolar disorder, not otherwise specified (BD NOS) and a family history of Bipolar I Disorder (BD) at baseline with rs-fMRI (functional magnetic resonance imaging) and functional connectivity (FC) analyses and compare data with previously acquired rs-fMRI and FC data from 20 age- and gender-matched healthy controls (HC). Subjects will then undergo a 12-week Mindfulness based stress reduction- teen (MBSR-T) intervention and be reassessed and rescanned. The intervention and scanning will take place in groups of 6-8 subjects/group/year over the 4 years. This proposal will be a natural progression of past research, while extending the investigators' expertise to include advanced FC analyses and mindfulness based interventions in youth with mood dysregulation. The investigators will also integrate trainees into the imaging and therapy components of this study, furthering our mission of mentoring the next generation of innovative researchers who will push the field forward.
| Status | Terminated |
| Enrollment | 14 |
| Est. completion date | September 2017 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 13 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Ages 13-17 - Diagnosed with BD-NOS - First or second degree relative diagnosed with bipolar I or II Exclusion Criteria: - Not English speaking - For those who are to participate in the MRI scan, having any metal in the body or movement disorders will be an exclusionary factor |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stanford University School of Medicine | Stanford | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dorsal Medial Network functional connectivity | (1) Use ICA to compare DMN in subjects with BD NOS to healthy controls (HC) | 12 weeks | |
| Primary | Functional connectivity of sgACC with thalamus, VMPFC, and amygdala | (2) Investigate level of FC of the sgACC with thalamus, VMPFC, amygdala, and FC of pCing with amygdala/hippocampus, comparing subjects to HC. | 12 weeks | |
| Secondary | Degree of Mindfulness | Will use measures of self report to determine amount and quality of mindfulness practice and degree of daily mindfulness achieved | 12 weeks |