Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI

Phase 4

Completed

• Conditions: Bipolar Disorder; Major Depression
• Interventions: Drug: Selective Serotonin Reuptake Inhibitor (SSRI)

• Registration Number: NCT01811147
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-14
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Results First Submitted: 2019-08-29
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-26
• Last Update Submitted: 2019-11-26
• Results First Posted: 2019-12-02
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Risk Depression	Selective Serotonin Reuptake Inhibitor (SSRI)	Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.
Low Risk Depression	Selective Serotonin Reuptake Inhibitor (SSRI)	Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant..

Primary Outcome Measures

Name	Time	Method
HAM-D 17 Item: Hamilton Depression Rating Scale	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 Outcome Measures

Name	Time	Method
YMRS: Young Mania Rating Scale	24 months	Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (\>25)

Trial Locations

Locations (1)

Cleveland Clinic Foundation Center for Behavioral Health; 🇺🇸 Cleveland, Ohio, United States