The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

NCT ID: NCT02804334

Last Updated: 2018-11-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-10-31

Brief Summary

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

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.

Conditions

Bipolar Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Volunteers

Participants with no current or lifetime psychiatric disorders

Psychiatric Questionnaires

Intervention Type: PROCEDURE

Blood draw

Intervention Type: PROCEDURE

Untreated Bipolar Disorder

Participants who meet criteria for current bipolar disorder but who are not currently taking any psychotropic medications

Psychiatric Questionnaires

Intervention Type: PROCEDURE

Blood draw

Intervention Type: PROCEDURE

Interventions

Psychiatric Questionnaires

Intervention Type: PROCEDURE

Blood draw

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

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

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CellPrint Biotechnology

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keming Gao

Clinical Director, Mood Disorders Program, UH Cleveland Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keming Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

02-16-34

Identifier Type: -

Identifier Source: org_study_id