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Completed

NCT Number: NCT00835120

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

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.

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Key information

Conditions

Metabolic Syndrome Bipolar Depression Bipolar Disorder Bipolar and Related Disorders Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Mood Disorders Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

pioglitazone

Drug

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 names: Actos

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score

    Time frame: Week 0 - Week 8

    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

  2. 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

    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.

  3. Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores

    Time frame: Week 0 - Week 8

    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.

  4. Change in Clinical Global Impressions-Bipolar Version (CGI-BP)

    Time frame: Week 0 - Week 8

    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.

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • National Alliance for Research on Schizophrenia and Depression
  • Takeda Pharmaceuticals North America, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 3, 2009
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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