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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

Tracking Information
First Submitted Date June 8, 2016
First Posted Date June 17, 2016
Last Update Posted Date November 1, 2018
Study Start Date June 2016
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2016)
  • Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls [ Time Frame: Day 1 ]
  • Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
Official Title The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Bipolar Disorder
Intervention
  • Procedure: Psychiatric Questionnaires
  • Procedure: Blood draw
Study Groups/Cohorts
  • Healthy Volunteers
    Participants with no current or lifetime psychiatric disorders
    Interventions:
    • 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
    Interventions:
    • Procedure: Psychiatric Questionnaires
    • Procedure: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: October 31, 2018)
29
Original Estimated Enrollment
 (submitted: June 14, 2016)
80
Actual Study Completion Date October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02804334
Other Study ID Numbers 02-16-34
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Keming Gao, University Hospitals Cleveland Medical Center
Study Sponsor University Hospitals Cleveland Medical Center
Collaborators CellPrint Biotechnology
Investigators
Principal Investigator: Keming Gao, MD, PhD University Hospitals Cleveland Medical Center
PRS Account University Hospitals Cleveland Medical Center
Verification Date October 2018