Back to resultsGao Bipolar Spectrum Lithium/Quetiapine Study
Primary Purpose
Bipolar Disorder
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lithium
Quetiapine
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- Able to provide informed consent before beginning any study-specific procedures
- Male and female patients at least 18 years of age
- Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s)
- Willing to be randomized to either Lithium or Quetiapine
- If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
- Women with reproductive potential must have a negative urine pregnancy test
Exclusion Criteria:
- Unwilling to comply with study requirements
- Patients who have had severe adverse reaction to Lithium or Quetiapine
- Patients who require inpatient care
- Drug/alcohol dependence requiring immediate acute detoxification
- Pregnancy as determined by serum pregnancy test or breastfeeding
- History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.
Sites / Locations
- University Hospitals Cleveland Medical Center - Mood Disorders Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lithium
Quetiapine
Arm Description
Outcomes
Primary Outcome Measures
Time to Study Discontinuation
The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Secondary Outcome Measures
Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
Full Information
NCT ID
NCT01526148
First Posted
January 25, 2012
Last Updated
July 18, 2017
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01526148
Brief Title
Gao Bipolar Spectrum Lithium/Quetiapine Study
Official Title
Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Ran out of funding
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a 4-month randomized open-label comparative safety, tolerability, and effectiveness trial of Lithium versus Quetiapine for subjects presenting in any phase of Bipolar who currently require a medication change for their illness. Stratified randomization will reduce bipolar type I , bipolar type II , or sub-threshold imbalance across cells. The enrollment goal is 60 subjects, over 24 months from initial regulatory approval. The primary outcome is the difference between lithium and quetiapine in the time to 'all cause' medication discontinuation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lithium
Arm Type
Active Comparator
Arm Title
Quetiapine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lithium
Other Intervention Name(s)
Lithium Carbonate, Eskalith
Intervention Description
Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Primary Outcome Measure Information:
Title
Time to Study Discontinuation
Description
The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Description
Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
Time Frame
Screening and Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able to provide informed consent before beginning any study-specific procedures
Male and female patients at least 18 years of age
Meets Diagnostic and Statistical Manual -IV criteria for BPI, BP II, or National Comorbidity Survey-R criteria for sub-threshold BP with or without symptoms, in need of medication adjustment(s)
Willing to be randomized to either Lithium or Quetiapine
If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation
Women with reproductive potential must have a negative urine pregnancy test
Exclusion Criteria:
Unwilling to comply with study requirements
Patients who have had severe adverse reaction to Lithium or Quetiapine
Patients who require inpatient care
Drug/alcohol dependence requiring immediate acute detoxification
Pregnancy as determined by serum pregnancy test or breastfeeding
History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keming Gao, MD, PhD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center - Mood Disorders Program
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
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Gao Bipolar Spectrum Lithium/Quetiapine Study
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