Metabolic SyndromePhase 4NCT00835120
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
A Phase 4 study testing Pioglitazone in people with Metabolic Syndrome and Bipolar Depression, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metabolic Syndrome, Bipolar Depression, Insulin Resistance
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Be male or female between the ages of 18 and 70
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar disorder (type I, II, or NOS)
- Currently depressed as confirmed by the MINI-Plus at the screening visit
- Currently receiving treatment with an anti-manic drug
- Meets criteria for metabolic syndrome or insulin resistance
Who cannot join
- Pregnancy or breast feeding
- Unstable or inadequately treated medical illness as judged by the investigator
- Severe personality disorder
- Serious suicidal risk
- Known history of intolerance or hypersensitivity to pioglitazone
- Treatment with pioglitazone in the 3 months prior to randomization
Show all 15Show fewer
- Dependence on alcohol or drugs (other than nicotine) in the 3 months prior to study entry
- Currently taking an antidiabetic/glucose-lowering agent.
- Diagnosed with dementia
- Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15
- Diagnosed with heart failure
- Transaminase elevation >2.5 times the upper limit of normal
- Presence of renal impairment (eg. creatinine > 1.5)
- Fasting blood glucose >150 mg/dL
- Hb A1c > 7.5%
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
- Conditions
- Metabolic Syndrome, Bipolar Depression, Insulin Resistance
- Being tested
- Pioglitazone
- Medical subject headings
- Metabolic Syndrome, Bipolar Disorder, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
Measured: Week 0 - Week 8
Secondary outcomes (4)
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome
Measured: Week 0 - Week 8
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.
Measured: Week 0 - Week 8
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.
Measured: Week 0 - Week 8
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Measured: Week 0 - Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.
- Responsible party
- Principal investigator, Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
- Investigators
- David E Kemp, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00835120
- Sponsor's protocol ID
- 07-08-24
- Status last verified
- Nov 2016
- First submitted
- 2 Feb 2009
- Last updated
- 26 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kemp DE, Schinagle M, Gao K, Conroy C, Ganocy SJ, Ismail-Beigi F, Calabrese JR. PPAR-gamma agonism as a modulator of mood: proof-of-concept for pioglitazone in bipolar depression. CNS Drugs. 2014 Jun;28(6):571-81. doi: 10.1007/s40263-014-0158-2.
PubMed 24715548
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
- ClinicalTrials.gov ID
- NCT00835120
- Acronym / sponsor ID
- 07-08-24
- Conditions
- Metabolic Syndrome, Bipolar Depression, Insulin Resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.
- Study start
- Mar 2009
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Feb 2009 (estimated)
- Results
- Posted 17 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: PioglitazonePioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be male or female between the ages of 18 and 70
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of bipolar disorder (type I, II, or NOS)
- Currently depressed as confirmed by the MINI-Plus at the screening visit
- Currently receiving treatment with an anti-manic drug
- Meets criteria for metabolic syndrome or insulin resistance
Key exclusion criteria (15 listed)
- Pregnancy or breast feeding
- Unstable or inadequately treated medical illness as judged by the investigator
- Severe personality disorder
- Serious suicidal risk
- Known history of intolerance or hypersensitivity to pioglitazone
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 |
|---|---|---|
| PioglitazoneAlso: ActosAn open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day. | Drug | Pioglitazone |
Primary outcome
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
Time frame: Week 0 - Week 8
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
4 secondary outcomes
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
Time frame: Week 0 - Week 8
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
Time frame: Week 0 - Week 8
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
Time frame: Week 0 - Week 8
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
Time frame: Week 0 - Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24715548Kemp DE, Schinagle M, Gao K, Conroy C, Ganocy SJ, Ismail-Beigi F, Calabrese JR. PPAR-gamma agonism as a modulator of mood: proof-of-concept for pioglitazone in bipolar depression. CNS Drugs. 2014 Jun;28(6):571-81. doi: 10.1007/s40263-014-0158-2.
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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.
David E Kemp, MD 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?
A Phase 4 study testing Pioglitazone in people with Metabolic Syndrome and Bipolar Depression, 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 15 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 26 Jan 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score (time frame: Week 0 - Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00835120, which also lists 1 linked publication.
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 26 Jan 2017.