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Seroquel™ (quetiapine) Clinical Trial report summaries

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.
D144AL00002A 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.
D144CC00002A Multicenter, Double-blind, Randomized, Parallel-group, Placebocontrolled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression

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 24-Week, International, Multi-centre, Open-label, Flexible-dose, Randomised, Parallel-Group, Phase IV Study to Compare the Effect on Glucose Metabolism of Quetiapine, Olanzapine, and Risperidone in the Treatment of Patients with Schizophrenia .

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.
D1444C00146A 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)
  D1448C00001A 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)
  D1448C00002A Multicenter, Double-blind, Randomized, Parallel-group, Placebocontrolled and Active-controlled 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 (Diamond Study)
  D1448C00003A 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)
D1448C00004A 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)
  D1448C00007A 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)
D1448C00011An 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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