Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder-Not Otherwise Specified

Bipolar Disorder Clinical Trial

Official title:

Brain Connectivity and Mindfulness Training in Youth With Bipolar Disorder NOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02095483
• Other study ID #: 27425
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 20, 2014
• Start date: March 2014
• Est. completion date: January 2019

Study information

• Verified date: March 2014
• Source: Stanford University
• Contact: Paige J Staudenmaier, BA
• Phone: 650-725-6760
• Email: pstaudenmaier[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study seeks to test the effectiveness of mindfulness based therapy on neural network in youth at high risk for developing bipolar disorder. TO do this, the investigators propose to conduct a brain scan in adolescents before and after participation in a 12 week mindfulness based stress reduction program. The investigators will also assess behavioral outcome measures before and after completing the mindfulness based therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Ages 13-18, diagnosed with bipolar disorder-not otherwise specified, first or second degree relative diagnosed with bipolar I or II.

Exclusion Criteria:

• Not English speaking. For those who are to participate int he scan, having any metal in the body or movement disorders will be an exclusionary factor

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Behavioral:
• Mindfulness Group Therapy Study

Locations

Country	Name	City	State
United States	Stanford Behavioral Sciences and Psychiatry	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale	depression rating within 2 week time frame	change from baseline after 12 weeks of therapy	Yes
Secondary	Children's Affective Lability Scale	measures degree of mood lability	change from baseline after 12 weeks of thera	No
Secondary	Young Mania Rating Scale	measures mania rating within 1 week time frame	change from baseline after 12 weeks of thera	No