Bipolar DisorderNCT01342380
Pioglitazone and Quetiapine XR Pharmacogenetic Study
An observational study of Bipolar Disorder and Major Depressive Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder, Major Depressive Disorder
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2015
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 310 subjects between the ages of 18 and 70 will be targeted for enrollment. We anticipate a low enrollment rate of 200 from the targeted 310 participants. Eligible participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise specified) or DSM-IV major depressive disorder, as determined by extensive clinical interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus). Participants will be approached for enrollment if they are currently enrolled in one of four studies: IRB protocol numbers 10-06-19, 12-07-29, 07-07-20, and 07-08-24. Please see these protocols for additional study specific information.
Who may be able to join
- Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24
- Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study
- Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder
- Patient must be at least 18 years old
- Patient must be willing to give a blood sample
Who cannot join
- Patient lacks the capacity to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders
Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Seroquel | Participants who received Seroquel | |
| Pioglitazone | Participants who received pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic markers associated with treatment response
Genetic markers in PPARG, 5-HT2A, CYP3A4 and CYP2C8 genes known to be related in the pharmacodynamics and pharmacokinetics of pioglitazone or quetiapine XR will be associated with treatment response.
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2015
- Study completionMay 2015
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Jinbo Fan, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342380
- Sponsor's protocol ID
- #10-10-25
- Status last verified
- Jul 2023
- First submitted
- 25 Apr 2011
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic Study of Pioglitazone and Quetiapine XR Treatment Response in Mood Disorders
- ClinicalTrials.gov ID
- NCT01342380
- Acronym / sponsor ID
- #10-10-25
- Conditions
- Bipolar Disorder, Major Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Study start
- Feb 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 27 Apr 2011 (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.
Obtain phenotypic data and a DNA/blood sample from mood disorder patients undergoing pioglitazone or quetiapine XR treatment as a part of an IRB approved clinical trial conducted at the Mood Disorders Program. Pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (IRB # 07-08-24) and unipolar depression (IRB # 07-07-20). Quetiapine XR treatment is examined in generalized anxiety disorder comorbid with bipolar depression (IRB # 10-06-19) and unipolar depression (IRB # 12-01-29). Please refer to the respective IRB protocols for more information.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seroquel | – | –Participants who received Seroquel |
| Pioglitazone | – | –Participants who received pioglitazone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 310 subjects between the ages of 18 and 70 will be targeted for enrollment. We anticipate a low enrollment rate of 200 from the targeted 310 participants. Eligible participants will be diagnosed with DSM-IV bipolar disorder (type I, II, or not otherwise specified) or DSM-IV major depressive disorder, as determined by extensive clinical interview and the Mini-International Neuropsychiatric Interview-Plus (MINI-Plus). Participants will be approached for enrollment if they are currently enrolled in one of four studies: IRB protocol numbers 10-06-19, 12-07-29, 07-07-20, and 07-08-24. Please see these protocols for additional study specific information.
Key inclusion criteria (5 listed)
- Must have participated in IRB protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24
- Patient must give consent to participate, sign and date the IRB approved written informed consent form prior to the initiation of any procedures for this study
- Patient must be diagnosed with Bipolar Disorder or Major Depressive Disorder
- Patient must be at least 18 years old
- Patient must be willing to give a blood sample
Key exclusion criteria (1 listed)
- Patient lacks the capacity to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic markers associated with treatment response
Time frame: Up to 1.5 years
Genetic markers in PPARG, 5-HT2A, CYP3A4 and CYP2C8 genes known to be related in the pharmacodynamics and pharmacokinetics of pioglitazone or quetiapine XR will be associated with treatment response.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
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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.
Jinbo Fan, PhD principal investigator
Case Western Reserve University
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 and Major Depressive 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 18 Jul 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genetic markers associated with treatment response (time frame: Up to 1.5 years). 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 18 Jul 2023.