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The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804334
Recruitment Status : Terminated
First Posted : June 17, 2016
Last Update Posted : November 1, 2018
Sponsor:
Collaborator:
CellPrint Biotechnology
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment
Bipolar Disorder Procedure: Psychiatric Questionnaires Procedure: Blood draw

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.

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Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
Study Start Date : June 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Group/Cohort Intervention/treatment
Healthy Volunteers
Participants with no current or lifetime psychiatric disorders
Procedure: Psychiatric Questionnaires
Procedure: Blood draw
Untreated Bipolar Disorder
Participants who meet criteria for current bipolar disorder but who are not currently taking any psychotropic medications
Procedure: Psychiatric Questionnaires
Procedure: Blood draw



Primary Outcome Measures :
  1. Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls [ Time Frame: Day 1 ]
  2. Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls [ Time Frame: Day 1 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll 70 subjects. Thirty-five subjects will have bipolar I or II and are currently not taking any psychotropic medications and 35 subjects will be healthy controls.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804334


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
CellPrint Biotechnology
Investigators
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Principal Investigator: Keming Gao, MD, PhD University Hospitals Cleveland Medical Center
Additional Information:
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Responsible Party: Keming Gao, Clinical Director, Mood Disorders Program, UH Cleveland Medical Center, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02804334    
Other Study ID Numbers: 02-16-34
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders