Clinical trial NCT00835120: Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Official title: Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Metabolic Syndrome
Bipolar Depression
Insulin Resistance
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: Takeda Pharmaceuticals North America, Inc.
First posted: 2009-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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%

Primary outcomes:
measure: Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
timeFrame: Week 0 - Week 8
Secondary outcomes:
measure: Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
timeFrame: Week 0 - Week 8
measure: Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
timeFrame: Week 0 - Week 8
measure: Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
timeFrame: Week 0 - Week 8
measure: Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
timeFrame: Week 0 - Week 8
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David E Kemp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.