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Phase 3 /Seroquel SR Acute Mania Monotherapy - US

2014-08-27 03:40:40 | BioPortfolio

Summary

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Mania for 3 weeks.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Affective Psychosis, Bipolar

Intervention

Quetiapine fumarate (Seroquel) SR

Location

Research Site
Phoenix
Arizona
United States

Status

Completed

Source

AstraZeneca

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:40-0400

Clinical Trials [1049 Associated Clinical Trials listed on BioPortfolio]

Phase III/Seroquel SR Bipolar Depression Monotherapy - US

The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 we...

Seroquel in Bipolar Depression Versus Lithium

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followe...

Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania

The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of children and adolescent patients with Bipolar I ...

Seroquel in Bipolar Depression Versus SSRI

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is conti...

Quetiapine Fumarate (SEROQUEL) in the Treatment of Adolescent Patients With Schizophrenia and Bipolar I Disorder

The purpose of this study is to demonstrate the efficacy and safety of quetiapine fumarate (SEROQUEL) in the treatment of adolescent patients with schizophrenia and bipolar I disorder.

PubMed Articles [1569 Associated PubMed Articles listed on BioPortfolio]

Treatment outcomes of acute bipolar depressive episode with psychosis.

The impact of psychosis on the treatment of bipolar depression is remarkably understudied. The primary aim of this study was to compare treatment outcomes of bipolar depressed individuals with and wit...

A Test of the Transdiagnostic Dopamine Hypothesis of Psychosis Using Positron Emission Tomographic Imaging in Bipolar Affective Disorder and Schizophrenia.

The dopamine hypothesis suggests that dopamine abnormalities underlie psychosis, irrespective of diagnosis, implicating dopamine dysregulation in bipolar affective disorder and schizophrenia, in line ...

Mania triggered by sleep loss and risk of postpartum psychosis in women with bipolar disorder.

Women with bipolar disorder are at high risk of affective psychoses following childbirth (i.e. "postpartum psychosis", PP) and there is a need to identify which factors underlie this increased risk. V...

Cognitive functioning in first episode bipolar I disorder patients with and without history of psychosis.

Psychosis in bipolar I disorder (BDI) has been associated with increased cognitive dysfunction, which may relate to poorer functional outcomes. However, it is not known whether cognition differs betwe...

How long does the pharmacokinetic interaction between carbamazepine and quetiapine last after carbamazepine withdrawal?

Carbamazepine and quetiapine are drugs that are used as mood stabilizers in the treatment of bipolar disorders. A series of studies has shown that concurrent use of carbamazepine decreases quetiapine ...

Medical and Biotech [MESH] Definitions

A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER.

Agents that are used to treat bipolar disorders or mania associated with other affective disorders.

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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