Seroquel™ (quetiapine) was first approved in 1997 for schizophrenia. Since the formation of AstraZeneca, Seroquel™ (quetiapine) has received approval for bipolar mania. Please consult the prescribing information for the country concerned for guidance on the approved use of Seroquel™ (quetiapine). | Study Number | Completed Clinical Trial Report Summaries | 5077IL_0039 | A Multicenter, Double-blind Comparison of Efficacy and Safety of Seroquel™ (Quetiapine Fumarate), Haloperidol, and Placebo in the Treatment of Elderly Subjects Residing in Nursing Homes or Assisted Care Facilities and Presenting with Alzheimer’s Dementia and Psychoses or Other Selected Psychoses | 5077IL_0050 | A Multicentre, Double-blind, Randomised Trial to Compare the Effects of Quetiapine and Haloperidol Treatment Strategies on Treatment Outcomes (5077IL/0050[ESTO]) | 5077IL_0099 | A Multicenter, Double-blind, Randomized, Placebo-controlled Trial of the Safety and Efficacy of Seroquel™ (Quetiapine Fumarate) as Add-on Therapy with Lithium or Divalproex in the Treatment of Acute Mania | 5077IL_0100 | An International, Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Seroquel™ (Quetiapine Fumarate) as Add-on Therapy with Lithium or Divalproex in the Treatment of Acute Mania | 5077IL_0104 | An International, Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Seroquel™ (Quetiapine Fumarate) and Haloperidol as Monotherapy in the Treatment of Acute Mania | 5077IL_0105 | An International, Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Seroquel™ (Quetiapine Fumarate) and Lithium as Monotherapy in the Treatment of Acute Mania | 5077US_0043 | A Multicenter, Double-blind, Randomized Comparison of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™) and Risperidone (RISPERDAL™) in the Treatment of Patients with Schizophrenia | 5077US_0046 | A Multicenter, Double-blind, Randomized Comparison of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™) and Placebo in the Treatment of Agitation Associated with Dementia | 5077US_0049 | A Multicenter, Double-blind, Randomized, Placebo-controlled, Double-dummy Trial of the Use of Quetiapine Fumarate (Seroquel™) in the Treatment of Patients with Bipolar Depression | D1447C00001 | An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks. | D1447C00135 | A Confirmatory Multicenter, Double-blind, Randomized, Placebo-controlled Study of the Use of Quetiapine Fumarate (Seroquel™) in the Treatment of Patients with Bipolar Depression. | D1444C00132 | A 6-week, International, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL™ ) and Placebo in the Treatment of Acutely Ill Patients with Schizophrenia. | D1444C00133 | A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL™) and Placebo in the Treatment of Acutely Ill Patients with Schizophrenia.
| 5077IL_0041 | A Multicenter, Double-blind, Randomized Comparison of the Efficacy and Safety of Sustained-release Formulation Quetiapine Fumarate (SEROQUEL™) and Placebo in the Treatment of Patients With Schizophrenia. | | D144AL00002 | A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double- Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) versus Placebo as Adjunct Therapy with Mood Stabilizers (Lithium or Divalproex) for the Treatment of Alcohol Dependence in Patients with Bipolar I Disorder. | D1441C00023 | A Canadian, Multicentre, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment with Higher Doses of Quetiapine Fumarate (Seroquel™) greater than 800 mg/day in Schizophrenic or Schizoaffective Subjects. | D1441C00125(5077IL/125) | A Canadian, Multicentre, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment with Higher Doses of Quetiapine Fumarate (Seroquel™) greater than 800 mg/day in Schizophrenic or Schizoaffective Subjects. | 1441C09907 | Westenberg OCD study. | D1440L00006 | A Double dummy & double blind, Multicenter, Randomized Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) and Lithium as Monotherapy in the Treatment of Acute Mania in Patients with Bipolar Disorder | D1441L00002 | Efficacy and Tolerability of Olanzapine, Quetiapine and Risperidone in the Treatment of First Episode Psychosis: A Randomized Double Blind 52 Week Comparison. | D1443L00004 | A 24-week, Multi-Centre, Open-label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) with Daily Dose 600mg-750mg as Mono-therapy in the Treatment of Acute chizophrenic Patients. | BU-5077-0011 (D1441L00028) | Trial results awaiting further analysis and interpretation. Anticipated posting date is October 2008. | D1446L00002 | A Multicenter, Double-blind, Randomized Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUELâ) and Placebo in the Treatment of Agitation Associated with Dementia | D1444C00004 (PRINCESS) | A 1-year, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Phase III Study to Evaluate Prevention of Relapse in Patients in Stable Condition with Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo. | | D1444C00146 | A 6-week International, Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study to Evaluate the Feasibility of Switching from Immediate-release Quetiapine Fumarate (SEROQUEL™) to Sustained-release Quetiapine Fumarate (400 to 800 mg/day) in Outpatients with Schizophrenia . | D1444C00147 | A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching any Antipsychotic Treatment to Sustained-release quetiapine Fumarate (SEROQUELâ) in Patients with Schizophrenia | D1447C00001 | An International, Multi-centre, Double-blind, randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks | D1447C00126 | A Multicenter, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Tablets 400 mg to 800 mg Daily in Divided Doses) to Placebo when Used as Adjunct to a Mood Stabilizer (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients | D1447C00127 | A Multicenter, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Tablets 400 mg to 800 mg Daily in Divided Doses) to Placebo when Used as Adjunct to a Mood Stabilizer (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Adult Patients | D1447C00134 | An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Paroxetine as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks. | D1441C00149 | Trial results awaiting further analysis and interpretation. Anticipated posting date is January 2009. | D1443L00003 | RAPID – An Open-Label, Randomised, Multicentre Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), over 14 Days, in Acute Schizophrenia / Schizoaffective Disorder (Rapid versus Conventional Titration) | | D1448C00001 | A Multicenter, Double-blind, Randomized, Parallel-group, Placebocontrolled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Extended-release (SEROQUEL®) as Monotherapy in the Treatment of Patients with Major Depressive Disorder (Moonstone Study) | | D1448C00003 | A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (SEROQUEL XR) as Mono-Therapy in the Treatment of Adult Patients with Major Depressive Disorder (OPAL STUDY) | | D1448C00004 | A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo-Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (SEROQUEL XR™) as Mono-Therapy in the Treatment of Adult Patients with Major Depressive Disorder (AMBER STUDY) | | D1448C00007 | A Multicenter, Double-blind, Randomized, Parallel-group, Placebocontrolled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Extended-release (SEROQUEL XR™) in Combination with an Antidepressant in the Treatment of Patients with Major Depressive Disorder with Inadequate Response to an Antidepressant Treatment (Onyx Study) | | D1448C00011 | An International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-controlled Study of the Efficacy and Safety of Sustained-release Quetiapine Fumarate (Seroquel SR™) in the Treatment of Generalized Anxiety Disorder (SILVER Study) | D1449L00003 | Fast Titration of Quetiapine versus Currently Approved Titration: A Randomized, Multicentre, Parallel Group, Open Trial in Schizophrenia and Schizoaffective Disorder. |
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