Bipolar DisorderNCT02804334
The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
An observational study of Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The goal of this project is to study ~45 molecules in blood cells that may differentiate patients with bipolar disorder from healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psychiatric Questionnaires and Blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- For inclusion in this study, subjects must meet all of the following criteria:
- 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.
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- For inclusion in this study, subjects must meet all of the following criteria:
- 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.
Who cannot join
- Any of the following is regarded as a criterion for exclusion from the study:
- 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.
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- A lifetime history of a psychiatric disorder
- Any of the following is regarded as a criterion for exclusion from the study:
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The goal of this project is to study ~45 molecules in blood cells that may differentiate patients with bipolar disorder from healthy controls.
Read the 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
- Being tested
- Psychiatric Questionnaires, Blood draw
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric QuestionnairesProcedure or surgery
Blood drawProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Participants with no current or lifetime psychiatric disorders Receives: 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 Receives: Procedure: Psychiatric Questionnaires; Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls
Measured: Day 1
Specificity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- CellPrint Biotechnology
- Responsible party
- Principal investigator, Keming Gao, University Hospitals Cleveland Medical Center
- Investigators
- Keming Gao, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804334
- Sponsor's protocol ID
- 02-16-34
- Status last verified
- Oct 2018
- First submitted
- 8 Jun 2016
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Molecules in Blood Cells for Diagnosing Bipolar Disorders
- ClinicalTrials.gov ID
- NCT02804334
- Acronym / sponsor ID
- 02-16-34
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- CellPrint Biotechnology
- Study start
- Jun 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Procedure: Psychiatric Questionnaires, Procedure: Blood drawParticipants with no current or lifetime psychiatric disorders |
| Untreated Bipolar Disorder | – | Procedure: Psychiatric Questionnaires, Procedure: Blood drawParticipants who meet criteria for current bipolar disorder but who are not currently taking any psychotropic medications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric Questionnaires | Procedure or surgery | Healthy Volunteers, Untreated Bipolar Disorder |
| Blood draw | Procedure or surgery | Healthy Volunteers, Untreated Bipolar Disorder |
Primary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keming Gao, MD, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of ~45 molecules in blood cells of patients with bipolar I or II disorder versus healthy controls (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2018.