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

Condition(s) targeted: Metabolic Syndrome; Bipolar Depression; Insulin Resistance

Intervention: Pioglitazone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
David E Kemp, MD, Principal Investigator, Affiliation: Univeristy Hospitals Case Medical Center

Overall contact:
Liz Fein, MA, Phone: 216-844-2863, Email: Elizabeth.Fein@UHhospitals.org

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.

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

Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) score

Secondary outcome:

Change in Montgomery-Asberg Depression Rating Scale (MADRS) score

Response rates on the IDS-CR, MADRS and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)

Remission rates based on IDS-CR, QIDS-SR, and MADRS scores

Change in Clinical Global Impressions-Bipolar Version (CGI-BP) and Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) scores

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Be male or female between the ages of 18 and 70

- 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%

Liz Fein, MA, Phone: 216-844-2863, Email: Elizabeth.Fein@UHhospitals.org

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States; Recruiting
Liz Fein, MA, Phone: 216-844-2863, Email: Elizabeth.Fein@UHhospitals.org
David E Kemp, MD, Principal Investigator

Starting date: March 2009
Ending date: February 2011
Last updated: June 12, 2009