Gao Bipolar Spectrum Lithium/Quetiapine Study

Bipolar Disorder Clinical Trial

Official title:

Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01526148
• Other study ID #: 09-11-01
• Status: Terminated
• Phase: Phase 4
• First received: January 25, 2012
• Last updated: October 1, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lithium
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.
• Quetiapine
Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center - Mood Disorders Program	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Case Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 16	No
Secondary	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.	Screening and Week 16	No