Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, 44195, United States
NCT Number: NCT01811147
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.
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Notify Me15 year–30 year
All sexes
Interventional
Phase 4
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
FOR BIPOLAR DEPRESSED PATIENTS:
Inclusion criteria
FOR ALL UNIPOLAR DEPRESSED PATIENTS:
ADDITIONAL INCLUSION CRITERIA FOR HIGH RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:
At least one of the following:
ADDITIONAL INCLUSION CRITERIA FOR LOW RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:
Exclusion criteria
FOR DEPRESSION AND BIPOLAR SUBJECTS:
Inclusion criteria
FOR HEALTHY CONTROLS: Healthy subjects matched for age, gender and ethnicity will be included
Exclusion criteria
FOR HEALTHY CONTROLS:
Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
Other names: Serotonin-norepinephrine reuptake inhibitor
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).
Time frame: 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)
The Cleveland Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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