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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
Results First Received: September 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Insulin Resistance
Interventions: Drug: Pioglitazone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Pioglitazone 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.
Placebo 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.

Participant Flow:   Overall Study
    Pioglitazone   Placebo
STARTED   17   20 
COMPLETED   12   15 
NOT COMPLETED   5   5 
Lost to Follow-up                2                3 
Lack of Efficacy                1                1 
Adverse Event                1                0 
Required Medication Change                0                1 
New Substance Use Disorder                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pioglitazone 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.
Placebo 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.
Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   20   37 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.71  (12.071)   43.65  (12.979)   45.05  (12.492) 
Gender 
[Units: Participants]
Count of Participants
     
Female      10  58.8%      14  70.0%      24  64.9% 
Male      7  41.2%      6  30.0%      13  35.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  35.3%      6  30.0%      12  32.4% 
White      11  64.7%      14  70.0%      25  67.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Bipolar Diagnosis 
[Units: Participants]
Count of Participants
     
BP 1   11   13   24 
BP 2   5   7   12 
BP NOS   1   0   1 


  Outcome Measures

1.  Primary:   Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carla Conroy, MPH
Organization: Univeristy Hospitals Cleveland Medical Center
phone: 216-844-2871
e-mail: carla.conroy@UHhospitals.org



Responsible Party: Joseph Calabrese, MD, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01717040     History of Changes
Other Study ID Numbers: Kemp DBDAT
Study First Received: April 17, 2012
Results First Received: September 19, 2016
Last Updated: November 30, 2016