Gao Bipolar Spectrum Lithium/Quetiapine Study

This study has been terminated.
(Ran out of funding)
Information provided by (Responsible Party):
Dr. Keming Gao, University Hospital Case Medical Center Identifier:
First received: January 25, 2012
Last updated: October 1, 2015
Last verified: October 2015
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.

Condition Intervention Phase
Bipolar Disorder
Drug: Lithium
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder

Resource links provided by NLM:

Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Time to Study Discontinuation [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Screening and Week 16 ] [ Designated as safety issue: No ]
    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.

Enrollment: 43
Study Start Date: January 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lithium 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.
Other Names:
  • Lithium Carbonate
  • Eskalith
Active Comparator: Quetiapine Drug: Quetiapine
Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Other Name: Seroquel


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01526148

United States, Ohio
University Hospitals Case Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospital Case Medical Center
Principal Investigator: Keming Gao, MD, PhD University Hospital Case Medical Center
  More Information

Responsible Party: Dr. Keming Gao, Director, Mood & Anxiety Clinic, University Hospital Case Medical Center Identifier: NCT01526148     History of Changes
Other Study ID Numbers: 09-11-01 
Study First Received: January 25, 2012
Results First Received: July 30, 2015
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents processed this record on May 03, 2016