search
Back to results

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

Primary Purpose

Metabolic Syndrome, Bipolar Depression, Insulin Resistance

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pioglitazone
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be male or female between the ages of 18 and 70
  • Diagnostic and Statistical Manual of Mental Disorders (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%

Sites / Locations

  • University Hospitals Cleveland Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pioglitazone

Arm Description

Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes

Outcomes

Primary Outcome Measures

Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome

Secondary Outcome Measures

Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.

Full Information

First Posted
February 2, 2009
Last Updated
November 30, 2016
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00835120
Brief Title
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Official Title
Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Bipolar Depression, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Experimental
Arm Description
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Other Intervention Name(s)
Actos
Intervention Description
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Primary Outcome Measure Information:
Title
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
Description
Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
Time Frame
Week 0 - Week 8
Secondary Outcome Measure Information:
Title
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
Description
The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome
Time Frame
Week 0 - Week 8
Title
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
Description
A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.
Time Frame
Week 0 - Week 8
Title
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
Description
A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.
Time Frame
Week 0 - Week 8
Title
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
Description
The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Time Frame
Week 0 - Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be male or female between the ages of 18 and 70 Diagnostic and Statistical Manual of Mental Disorders (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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E Kemp, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24715548
Citation
Kemp DE, Schinagle M, Gao K, Conroy C, Ganocy SJ, Ismail-Beigi F, Calabrese JR. PPAR-gamma agonism as a modulator of mood: proof-of-concept for pioglitazone in bipolar depression. CNS Drugs. 2014 Jun;28(6):571-81. doi: 10.1007/s40263-014-0158-2.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs