Gao Bipolar Spectrum Lithium/Quetiapine Study

NCT01526148 | Terminated Phase 4 Results DMC

• 1 other identifier: 09-11-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

  Screening and Week 16

Study Arms (2)

Lithium

ACTIVE COMPARATOR

Drug: Lithium

Quetiapine

ACTIVE COMPARATOR

Drug: Quetiapine

Interventions

Lithium 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.

Also known as: Lithium Carbonate, Eskalith

Lithium

Quetiapine DRUG

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

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center - Mood Disorders Program

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lithium; Lithium Carbonate; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Keming Gao, MD, PhD
• Organization: University Hospitals Cleveland Medical Center

keming.gao@UHhospitals.org

216-844-2865

Study Officials

• Keming Gao, MD, PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood & Anxiety Clinic

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 3, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: August 16, 2017
• Results First Posted: October 30, 2015

Record last verified: 2017-07

Locations

US (1)