Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
1 other identifier
interventional
34
1 country
1
Brief 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. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2009
CompletedFirst Posted
Study publicly available on registry
February 3, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
October 17, 2014
CompletedJanuary 26, 2017
November 1, 2016
4.1 years
February 2, 2009
October 10, 2014
November 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Week 0 - Week 8
Secondary Outcomes (4)
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
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)
Week 0 - Week 8
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
Week 0 - Week 8
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
Week 0 - Week 8
Study Arms (1)
Pioglitazone
EXPERIMENTALPioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Interventions
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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%
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 24715548DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carla Conroy
- Organization
- University Hospitals Case Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
David E Kemp, MD
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Mood Disorders Program
Study Record Dates
First Submitted
February 2, 2009
First Posted
February 3, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
January 26, 2017
Results First Posted
October 17, 2014
Record last verified: 2016-11