Pioglitazone for the Treatment of Insulin-Resistant and Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital Case Medical Center
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
David E. Kemp, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01717040
First received: April 17, 2012
Last updated: October 29, 2012
Last verified: October 2012

April 17, 2012
October 29, 2012
September 2012
May 2014   (final data collection date for primary outcome measure)
Change in IDS-C30 total score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01717040 on ClinicalTrials.gov Archive Site
  • Change in insulin resistance as quantified by homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
  • Change in fasting lipid profile [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pioglitazone for the Treatment of Insulin-Resistant and Bipolar Depression
Double-Blind, Placebo-Controlled Trial of Pioglitazone for Insulin-Resistant Bipolar Depression

The study is a double-blind, placebo-controlled 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression. All subjects will also meet criteria for insulin resistance (IR). The primary objective is to test the hypothesis that adjunctive pioglitazone is more effective than placebo for the relief of acute depressive symptoms resulting from bipolar disorder that is co-occurring with insulin resistance.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Bipolar Disorder
  • Insulin Resistance
  • Drug: Pioglitazone
    Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
    Other Name: Actos
  • Drug: Placebo
    Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
    Other Name: Sugar Pill
  • Experimental: Pioglitazone
    Intervention: Drug: Pioglitazone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be male or female >= 18 years of age
  • Diagnostic and Statistical Manual-IV (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 Insulin resistance
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.

Exclusion Criteria:

  • Pregnant or breast feeding
  • Unstable or inadequately treated medical illness as judged by the investigator
  • Severe personality disorder
  • Serious suicidal risk as judged by the investigator or having a score ≥ 4 on Montgomery Asberg Depression Rating Scale (MADRS) item number 10 (suicidal thoughts) at screening or baseline
  • 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 insulin or rosiglitazone.
  • Diagnosed with dementia
  • Acute Mania as defined by a Young Mania Rating Scale (YMRS) score > 15
  • Diagnosed with heart failure
  • History of bladder carcinoma
Both
18 Years and older
No
Contact: Carla Conroy 216-844-2871 carla.conroy@UHhospitals.org
United States
 
NCT01717040
Kemp DBDAT
Yes
David E. Kemp, MD, University Hospital Case Medical Center
University Hospital Case Medical Center
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Principal Investigator: David Kemp, MD University Hospital Case Medical Center
University Hospital Case Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP