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Pioglitazone for the Treatment of Bipolar Depression

This study has been terminated.
(The study ended early due to budgetary issues)
Sponsor:
Collaborator:
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Information provided by (Responsible Party):
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT01717040
First received: April 17, 2012
Last updated: November 30, 2016
Last verified: November 2016
April 17, 2012
November 30, 2016
September 2012
March 2016   (Final data collection date for primary outcome measure)
Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score [ Time Frame: Baseline and Week 8 ]
Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms
Change in IDS-C30 total score [ Time Frame: Baseline and Week 8 ]
Complete list of historical versions of study NCT01717040 on ClinicalTrials.gov Archive Site
Not Provided
  • Change in insulin resistance as quantified by homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: Baseline and Week 8 ]
  • Change in fasting lipid profile [ Time Frame: Baseline and Week 8 ]
Not Provided
Not Provided
 
Pioglitazone for the Treatment of Bipolar Depression
Double-Blind, Placebo-Controlled Trial of Pioglitazone for Bipolar Depression
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Terminated
37
March 2016
March 2016   (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-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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01717040
Kemp DBDAT
Yes
Not Provided
Plan to Share IPD: No
Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
The Depressive and Bipolar Disorder Alternative Treatment Foundation
Principal Investigator: David Kemp, MD University Hospitals Cleveland Medical Center
University Hospitals Cleveland Medical Center
November 2016

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