Adult Bipolar Mania


Tracking Information

Start Date  ICMJEJune 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2009)		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 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00931723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: July 1, 2009)
  • 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEAdult Bipolar Mania
Official Title  ICMJEAn 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
Brief Summary

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).

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEAcute Mania
Intervention  ICMJE
  • 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.
    Other Name: Seroquel XR
  • 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.
Study Arms / Comparison Groups
  • 1: Active Comparator
    Seroquel XR and Lithium
    Interventions:
    • Drug: Quetiapine fumarate XR
    • Drug: Lithium
    • Drug: Placebo
  • 2: Placebo Comparator
    Seroquel XR and placebo
    Interventions:
    • Drug: Quetiapine fumarate XR
    • Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE350
Estimated Completion DateJuly 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years to 65 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Quintiles Worldwideclinical.studies.ns@quintiles.com
Location Countries  ICMJEBelgium,   Bulgaria,   Germany,   India,   Israel,   Poland,   Russian Federation,   South Africa,   Ukraine

Administrative Information

NCT ID  ICMJENCT00931723
Responsible PartyMSD, AstraZeneca Pharmaceuticals
Study ID Numbers  ICMJED144AC00003
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJEQuintiles
Investigators  ICMJE
Study Director:Michael CastiglioneAstraZeneca
Principal Investigator:Michel Bourin, ProfesseurNeurobiologie de l'anxiété et de la dépression Faculté de Médecine
Information Provided ByAstraZeneca