Trials / Completed
CompletedNCT00931723
Adult Bipolar Mania
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 356 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2009-07-02
- Last updated
- 2012-04-19
- Results posted
- 2012-04-19
Locations
65 sites across 9 countries: Belgium, Bulgaria, Germany, India, Israel, Poland, Russia, South Africa, Ukraine
Source: ClinicalTrials.gov record NCT00931723. Inclusion in this directory is not an endorsement.