The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

Bipolar Disorder Clinical Trial

Official title:

The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02804334
• Other study ID #: 02-16-34
• Status: Terminated
• Start date: June 2016
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this project is to study ~45 molecules in blood cells that may differentiate patients with bipolar disorder from healthy controls.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Healthy Volunteers (Group 1)

For inclusion in this study, subjects must meet all of the following criteria:

1. Able to provide informed consent;

2. Male or female, at least 18 years of age;

3. Physically healthy

4. No current and/or lifetime psychiatric disorder assessed with the MINI for Diagnostic and Statistical Manual-5 (DSM-5);

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:

1. Unwilling to comply with study requirements;

2. Unwilling to have blood draw;

3. Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases and neurological disorders;

4. Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;

5. Currently pregnant.

6. 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:

1. Able to provide informed consent;

2. Male or female, at least 18 years of age;

3. Meets current DSM-5 criteria for bipolar type I (BPI) or bipolar type II (BP II) disorder as assessed by the MINI.

4. Depression severity should be measured with Montgomery-Asberg Depression Rating Scale (MADRS). A MADRS total score = 20 is required at Screening Visit/Baseline Evaluation.

5. 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)

6. Have not taken any psychotropic medications within the past 4 weeks;

7. 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:

1. Unwilling to comply with study requirements;

2. Unwilling to have blood draw;

3. Patients with chronic medical conditions such as diabetes, cardiovascular disease, immune diseases, infectious diseases, and neurological disorders;

4. Tests positive for illegal substances or prescriptions medications for which participants do not have a valid prescription;

5. Currently pregnant.

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease

Intervention

Procedure:
• Psychiatric Questionnaires

• Blood draw

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	CellPrint Biotechnology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls		Day 1
Primary	Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls		Day 1

External Links

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