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
- Conditions
- Health Condition 1: null- Acute Mania in Adult Patients
- Registration Number
- CTRI/2009/091/000538
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 350
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.
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 electronconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the YMRS total score from baseline to final assessment (Day 43).Timepoint: Will be scored at all visits.
- Secondary Outcome Measures
Name Time Method Changes in CGI-BP-S and CGI-BP-C score.Timepoint: Will be scored at all visits;Changes in YMRS scores in remission, response and change in total score.Timepoint: Will be scored at all visits;Incidence of AE's, including extrapyrimidal symptoms (EPS) and other specific safety areas, including somnolence, suicidality, neutropenia/agranulocytosis and diabetes mellitusTimepoint: Will be measured during the whole study period
Related Research Topics
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