Phase 4
N=356
Adult Bipolar Mania
Acute Mania
Bottom Line
View on ClinicalTrials.gov: NCT00931723 ↗Enrolled (actual)
356
Serious AEs
3.4%
Results posted
Apr 2012
Primary outcome: Primary: Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) — -22.8; -20.1 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Quetiapine fumarate XR (Drug); Lithium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43) |
-22.8; -20.1 | — |
| SECONDARY The Number of Patients With Clinically Significant Response. |
137; 120 | — |
| SECONDARY Remission |
125; 105 | — |
| SECONDARY Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness) |
-2.5; -2.2 | — |
| SECONDARY Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase) |
1.7; 1.9 | — |
| SECONDARY Improvement of Overall Bipolar Illness |
134; 125 | — |
| SECONDARY Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score |
-4.8; -4.1 | — |
| SECONDARY Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-19.2; -15.6 | — |
| SECONDARY Change From Baseline to Day 43 in PANSS Activation Subscale Score |
-7.1; -5.9 | — |
| SECONDARY Change From Baseline to Day 43 in PANSS Positive Subscale Score |
-8.1; -7.0 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 1 |
-1.8; -1.6 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 2 |
-1.9; -1.7 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 3 |
-1.3; -1.1 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 4 |
-2.0; -1.8 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 5 |
-3.1; -2.8 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 6 |
-3.1; -2.9 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 7 |
-1.5; -1.4 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 8 |
-3.1; -2.9 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 9 |
-2.5; -2.1 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 10 |
-1.1; -1.0 | — |
| SECONDARY Change From Baseline to Day 43 in Each YMRS Item Score No. 11 |
-1.4; -1.2 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00931723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.