NCT00931723
Completed
Phase 4
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
ConditionsAcute Mania
Overview
- Phase
- Phase 4
- Intervention
- Quetiapine fumarate XR
- Conditions
- Acute Mania
- Sponsor
- AstraZeneca
- Enrollment
- 356
- Locations
- 1
- Primary Endpoint
- Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
1
Seroquel XR and Lithium
Intervention: Quetiapine fumarate XR
1
Seroquel XR and Lithium
Intervention: Lithium
2
Seroquel XR and placebo
Intervention: Quetiapine fumarate XR
2
Seroquel XR and placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
Time Frame: Change in YMRS total score from baseline to Day 43.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Secondary Outcomes
- The Number of Patients With Clinically Significant Response.(43 days (from baseline to Day 43))
- Remission(Days 8 to 43)
- Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)(Change from baseline to Day 43.)
- Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)(Change from baseline to Day 43)
- Improvement of Overall Bipolar Illness(Day 43.)
- Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Change from baseline to Day 43.)
- Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in PANSS Activation Subscale Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in PANSS Positive Subscale Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 1(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 2(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 3(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 4(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 5(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 6(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 7(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 8(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 9(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 10(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 11(Change from baseline to Day 43)
Study Sites (1)
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