Pioglitazone for the Treatment of Insulin-Resistant and Bipolar Depression

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Insulin Resistance
Drug: Pioglitazone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled Trial of Pioglitazone for Insulin-Resistant Bipolar Depression

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Change in IDS-C30 total score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pioglitazone 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
Placebo Comparator: Placebo 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717040

Contacts
Contact: Carla Conroy 216-844-2871 carla.conroy@UHhospitals.org

Locations
United States, Ohio
University Hospitals Case Medical Center - Mood Disorders Program Recruiting
Cleveland, Ohio, United States, 44106
Contact: Carla Conroy    216-844-2871    Carla.Conroy@UHhospitals.org   
Principal Investigator: David Kemp, MD         
Sponsors and Collaborators
University Hospital Case Medical Center
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Investigators
Principal Investigator: David Kemp, MD University Hospital Case Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: David E. Kemp, MD, Director, Mood & Metabolic Clinic, University Hospital Case Medical Center
ClinicalTrials.gov Identifier: NCT01717040     History of Changes
Other Study ID Numbers: Kemp DBDAT
Study First Received: April 17, 2012
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospital Case Medical Center:
Bipolar Disorder
Insulin Resistance

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Insulin Resistance
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014