NCT01811147

Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 192 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Another purpose of this study is to use MRI images to determine which young adults with major depression may be at greater risk for developing mild or more severe symptoms of mania which suggests a diagnosis of bipolar disorder.

Detailed description

The study involves two phases, phase one includes the screening visit and MRI. The second phase, for depression participants, involves in person follow ups for up to two years. The second phase, for healthy and bipolar participants, involves phone follow ups, every three months for up to two years. The purpose of this study is listed above. We plan to enroll 200 participants total.

Conditions

• Bipolar Disorder
• Major Depression

Interventions

Type	Name	Description
DRUG	Selective Serotonin Reuptake Inhibitor (SSRI)	Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.

Timeline

• Start date: 2011-11-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2013-03-14
• Last updated: 2019-12-02
• Results posted: 2019-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study