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Clinical Trials/NCT01811147
NCT01811147
Completed
Phase 4

Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

The Cleveland Clinic1 site in 1 country192 target enrollmentNovember 2011

Overview

Phase
Phase 4
Intervention
Selective Serotonin Reuptake Inhibitor (SSRI)
Conditions
Bipolar Disorder
Sponsor
The Cleveland Clinic
Enrollment
192
Locations
1
Primary Endpoint
HAM-D 17 Item: Hamilton Depression Rating Scale
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
June 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

High Risk Depression

Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.

Intervention: Selective Serotonin Reuptake Inhibitor (SSRI)

Low Risk Depression

Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..

Intervention: Selective Serotonin Reuptake Inhibitor (SSRI)

Outcomes

Primary Outcomes

HAM-D 17 Item: Hamilton Depression Rating Scale

Time Frame: 24 months

Hamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).

Secondary Outcomes

  • YMRS: Young Mania Rating Scale(24 months)

Study Sites (1)

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