The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders

Terminated

• Conditions: Bipolar Disorder
• Interventions: Procedure: Psychiatric Questionnaires; Procedure: Blood draw

• Registration Number: NCT02804334
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Last Update Submitted: 2018-10-31
• Last Update Posted: 2018-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States