Working… Menu
Trial record 28 of 450 for:    QUETIAPINE

Gao Bipolar Spectrum Lithium/Quetiapine Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526148
Recruitment Status : Terminated (Ran out of funding)
First Posted : February 3, 2012
Results First Posted : October 30, 2015
Last Update Posted : August 16, 2017
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium Drug: Quetiapine Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder
Study Start Date : January 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Time to Study Discontinuation [ Time Frame: Week 16 ]
    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 :
  1. 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 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526148

Layout table for location information
United States, Ohio
University Hospitals Cleveland Medical Center - Mood Disorders Program
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Layout table for investigator information
Principal Investigator: Keming Gao, MD, PhD University Hospitals Cleveland Medical Center

Layout table for additonal information
Responsible Party: Keming Gao, Director, Mood & Anxiety Clinic, University Hospitals Cleveland Medical Center Identifier: NCT01526148     History of Changes
Other Study ID Numbers: 09-11-01
First Posted: February 3, 2012    Key Record Dates
Results First Posted: October 30, 2015
Last Update Posted: August 16, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Quetiapine Fumarate
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents