Adult Bipolar Mania

Official Title: “An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania”

The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).

Intervention(s) in this Clinical Trial

• Drug: Quetiapine fumarate XR
  • Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
• Drug: Lithium
  • Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
• Drug: Placebo
  • Oral treatment twice daily.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Seroquel XR and Lithium
• Placebo Comparator: 2
  • Seroquel XR and placebo

Primary Measures

• Change in the YMRS total score from baseline to final assessment (Day 43).
  • Time Frame: Will be scored at enrollment visit and then once a week for 6 weeks
    Safety Issue?: No

Secondary Measures

• Changes in YMRS scores in remission, response and change in total score.
  • Time Frame: Will be scored at enrollment visit and then once a week for 6 weeks
    Safety Issue?: No
• Changes in CGI-BP-S and CGI-BP-C score.
  • Time Frame: Will be scored at enrollment visit and then once a week for 6 weeks
    Safety Issue?: No

Inclusion Criteria:

• Provision of informed consent before any study procedures are performed.
• The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
• Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.

Exclusion Criteria:

• The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
• The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
• The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Michael Castiglione Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931723

Study ID Number: D144AC00003

ClinicalTrials.gov Identifier: NCT00931723

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products