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Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

This study has been completed.
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT00835120
First received: February 2, 2009
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Metabolic Syndrome
Bipolar Depression
Insulin Resistance
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

Resource links provided by NLM:


Further study details as provided by University Hospitals Cleveland Medical Center:

Primary Outcome Measures:
  • Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
    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.

  • Change in Clinical Global Impressions-Bipolar Version (CGI-BP) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 34
Study Start Date: March 2009
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Drug: Pioglitazone
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Other Name: Actos

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835120

Locations
United States, Ohio
University Hospitals ClevelandMedical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
National Alliance for Research on Schizophrenia and Depression
Takeda Pharmaceuticals North America, Inc.
Investigators
Principal Investigator: David E Kemp, MD Univeristy Hospitals Cleveland Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph Calabrese, MD, Director, Mood Disorders Program, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00835120     History of Changes
Other Study ID Numbers: 07-08-24 
Study First Received: February 2, 2009
Results First Received: October 10, 2014
Last Updated: October 3, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Insulin Resistance
Bipolar Disorder
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders
Mental Disorders
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016