Gao Bipolar Spectrum Lithium/Quetiapine Study

NCT ID: NCT01526148

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-01-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lithium

Group Type: ACTIVE_COMPARATOR

Lithium

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Quetiapine

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

Intervention Type: DRUG

Other Intervention Names

Lithium Carbonate; Eskalith; Seroquel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Keming Gao

Director, Mood & Anxiety Clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Keming Gao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

09-11-01

Identifier Type: -

Identifier Source: org_study_id