- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804334
The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is one study visit for this research protocol. Participants may complete this visit on the day that they sign consent. If there is an upcoming blood draw already scheduled for the participant, within the clinical research trial in which they are enrolled, they may decide to wait until then to receive their blood draw. In addition, if a subject has completed the protocol specific monitoring labs within the past 30 days, either for clinical or research purposes, they do not have to be repeated.
After obtaining the informed consent, all potential research participants will be assessed with a systemic clinical interview and a structured interview with the Mini-International Neuropsychiatric Interview (MINI). Psychiatric assessments will be administered to all participants, both healthy controls and participants diagnosed with bipolar disorder (BD). All eligible participants will also complete a Clinical Record Form. The form includes demographics, previous treatment history, the number of previous episodes, family history, and other historical correlates.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria for Healthy Volunteers (Group 1)
For inclusion in this study, subjects must meet all of the following criteria:
- Able to provide informed consent;
- Male or female, at least 18 years of age;
- Physically healthy
- No current and/or lifetime psychiatric disorder assessed with the MINI for Diagnostic and Statistical Manual-5 (DSM-5);
- Willing to have blood draw.
Exclusion Criteria for Healthy Volunteers (Group 1)
Any of the following is regarded as a criterion for exclusion from the study:
- Unwilling to comply with study requirements;
- Unwilling to have blood draw;
- Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases and neurological disorders;
- Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;
- Currently pregnant.
- A lifetime history of a psychiatric disorder
Inclusion Criteria for Untreated Bipolar Subjects (Group 2)
For inclusion in this study, subjects must meet all of the following criteria:
- Able to provide informed consent;
- Male or female, at least 18 years of age;
- Meets current DSM-5 criteria for bipolar type I (BPI) or bipolar type II (BP II) disorder as assessed by the MINI.
- Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score ≥ 20 is required at Screening Visit/Baseline Evaluation.
- Has experienced impairment as documented by a score consistent with moderate impairment (4 or more on at least one of the three subscales of the Sheehan Disability Scale (SDS), which includes an assessment of work-life, family-life, and social life (no/mild impairment 0-3, moderate impairment 4-6, severe impairment 7-10)
- Have not taken any psychotropic medications within the past 4 weeks;
- Willing to have blood draw.
Exclusion Criteria for Untreated Bipolar Subjects (Group 2)
Any of the following is regarded as a criterion for exclusion from the study:
- Unwilling to comply with study requirements;
- Unwilling to have blood draw;
- Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases, and neurological disorders;
- Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;
- Currently pregnant.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy Volunteers
Participants with no current or lifetime psychiatric disorders
|
|
Untreated Bipolar Disorder
Participants who meet criteria for current bipolar disorder but who are not currently taking any psychotropic medications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls
Time Frame: Day 1
|
Day 1
|
Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02-16-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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