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Pioglitazone for the Treatment of Bipolar Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University Hospital Case Medical Center
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:
NCT01717040
First received: April 17, 2012
Last updated: October 9, 2014
Last verified: October 2014
  Purpose

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. The secondary objectives are to determine potential moderators and mediators of antidepressant efficacy.


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 Bipolar Depression

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in Inventory of Depressive Symptomatology-Clinician Rated (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 2015
Estimated Primary Completion Date: May 2015 (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

Detailed Description:

The study is a double-blind, placebo-controlled 8-week trial of pioglitazone, either as monotherapy or adjunctive to a mood stabilizer, for the acute relief of bipolar depression. The enrollment goal is 80 subjects (40 patients each in the pioglitazone treatment group and the placebo treatment group).

Screening Phase: Patients who have been prescribed a mood stabilizer for > 4 weeks and are on a therapeutic dose will proceed directly to the Screening Visit. For situations in which the patient prefers to be taking a mood stabilizer or where the treating psychiatrist feels it is clinically necessary, a mood stabilizer (lithium, divalproex, carbamazepine, lamotrigine, olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone or lurasidone) will be initiated (see Mood Stabilizer Initiation section below). For this set of patients who do begin a mood stabilizer, the Screening Phase may last up to 8 weeks. Otherwise, subjects who do not come in on a mood stabilizer will proceed directly to screening.

Double-Blind, Placebo-Controlled Study Period (Week 1 to Week 8): Patients who meet inclusion/exclusion criteria will be randomized to study treatment at the baseline/randomization visit within 30 days of the screening visit. The efficacy and safety assessments will be carried out at baseline/randomization and then weekly or every two weeks for a total of 8 weeks.

  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-International Neuropsychiatric Interview (M.I.N.I.)-Plus at the screening visit
  • Inventory of Depressive Symptoms total score > 25 or Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16) > 11 at study baseline
  • 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
  • Transaminase elevation >2.5 times the upper limit of normal
  • Presence of renal impairment (eg. creatinine > 1.5)
  • History of bladder carcinoma
  • Fasting blood glucose >150 mg/dL and Hb A1c> 7%; participants meeting these criteria will be referred to an endocrinologist or their primary care physician for a diabetes evaluation and education.
  • Receiving acute series of electroconvulsive therapy
  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: NCT01717040

Contacts
Contact: Carla Conroy, BA 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, BA    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: Joseph Calabrese, MD, Director, Mood Disorders Program, 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 9, 2014
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
Insulin Resistance
Affective Disorders, Psychotic
Behavioral Symptoms
Glucose Metabolism Disorders
Hyperinsulinism
Mental Disorders
Metabolic Diseases
Mood Disorders
Pioglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014