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Gao Bipolar Spectrum Lithium/Quetiapine Study

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Lithium (Drug); Quetiapine (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Keming Gao, MD, PhD, Principal Investigator, Affiliation: University Hospital Case Medical Center

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.

Clinical Details

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

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

Primary outcome: Time to study discontinuation

Secondary outcome: Lithium vs. Quetiapine effects on general cardiovascular disease risk and role effects on general cardiovascular disease risk and role impairment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University Hospitals Case Medical Center - Mood Disorders Program, Cleveland, Ohio 44106, United States
Additional Information

Starting date: January 2012
Last updated: March 9, 2015

Page last updated: August 23, 2015

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