The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

NCT02804334 | Terminated DMC

• 1 other identifier: 02-16-34
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls

  Day 1

• Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls

  Day 1

Study Arms (2)

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

Interventions

Psychiatric Questionnaires PROCEDURE

Healthy Volunteers; Untreated Bipolar Disorder

Blood draw PROCEDURE

Healthy Volunteers; Untreated Bipolar Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• Unwilling to comply with study requirements;
• Unwilling to have blood draw;

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• CellPrint Biotechnology: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Keming Gao, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Mood Disorders Program, UH Cleveland Medical Center

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 17, 2016
• Study Start: June 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)