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Seroquel XR (Quetiapine Fumarate) - Summary

 



WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks) in these patients revealed a risk of death in the drug-treated patients of between 1.6 to 1.7 times that seen in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. SEROQUEL XR is not approved for the treatment of patients with Dementia-Related Psychosis.

 

SEROQUEL XR SUMMARY

SEROQUEL XR (quetiapine fumarate) is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives.

All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt.

SEROQUEL XR is indicated for the treatment of schizophrenia.

The efficacy of SEROQUEL XR in schizophrenia was established in part, on the basis of extrapolation from the established effectiveness of SEROQUEL. In addition, the efficacy of SEROQUEL XR was demonstrated in 1 short-term (6-week) controlled trial of schizophrenic inpatients and outpatients [ see Clinical Studies ].

The effectiveness of SEROQUEL XR in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use SEROQUEL XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [ See Dosage And Administration ].


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NEWS HIGHLIGHTS

Media Articles Related to Seroquel XR (Quetiapine)

Immune System Activated In Schizophrenia
Source: Immune System / Vaccines News From Medical News Today [2009.11.19]
Researchers at the Swedish medical university Karolinska Institutet have discovered that patients with recent-onset schizophrenia have higher levels of inflammatory substances in their brains. Their findings offer hope of being able to treat schizophrenia with drugs that affect the immune system. The causes of schizophrenia are largely unknown, and this hinders the development of effective treatments.

Major Schizophrenia Study Finds Striking Similarities Across 37 Countries In Six Regions
Source: Mental Health News From Medical News Today [2009.11.16]
An international study of more than 17,000 people with schizophrenia has found striking similarities in symptoms, medication, employment and sexual problems, despite the fact that it covered a diverse range of patients and healthcare systems in 37 different countries.

World's Leading Experts In Schizophrenia To Meet At 26th Annual Pittsburgh Schizophrenia Conference Nov. 13
Source: Schizophrenia News From Medical News Today [2009.11.08]
Internationally renowned experts in schizophrenia and other psychotic disorders, researchers and clinicians, patients and their families and friends will gather in Pittsburgh to discuss the latest in research and clinical advances at the 26th Annual Pittsburgh Schizophrenia Conference to be held Friday, Nov. 13, at the Sheraton Station Square, Pittsburgh.

Schizophrenia
Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2009.10.30]
Title: Schizophrenia
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 10/30/2009

Forest Laboratories, Inc. And Gedeon Richter Announce Positive Results From A Phase IIb Study Of Cariprazine For The Treatment Of Schizophrenia
Source: Schizophrenia News From Medical News Today [2009.10.29]
Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc announced positive top-line results from a Phase IIb clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of acute exacerbation of schizophrenia.

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Published Studies Related to Seroquel XR (Quetiapine)

Extended-release quetiapine fumarate (quetiapine XR): a once-daily monotherapy effective in generalized anxiety disorder. Data from a randomized, double-blind, placebo- and active-controlled study. [2009.08.20]
The efficacy and tolerability of extended-release quetiapine fumarate (quetiapine XR) once-daily monotherapy in generalized anxiety disorder (GAD) was assessed. This multicentre, double-blind, randomized, placebo- and active-controlled, phase III trial consisted of a 1- to 4-wk enrolment/wash-out period and a 10-wk (8-wk active treatment, 2-wk post-treatment drug-discontinuation) study period; 873 patients were randomized to 50 mg or 150 mg quetiapine XR, 20 mg paroxetine, or placebo...

A double-blind, placebo-controlled pilot study of quetiapine for depressed adolescents with bipolar disorder. [2009.08]
CONCLUSIONS: The results suggest that quetiapine monotherapy is no more effective than placebo for the treatment of depression in adolescents with bipolar disorder. However, limitations of the study, including the high placebo response rate, may have contributed to our findings and should be considered in the design of future investigations of pharmacological interventions for this population.

Quetiapine augments the effect of citalopram in non-refractory obsessive-compulsive disorder: a randomized, double-blind, placebo-controlled study of 76 patients. [2009.07]
CONCLUSIONS: The combination of quetiapine and citalopram was more effective than citalopram alone in reducing OCD symptoms in treatment-naive or medication-free OCD patients. TRIAL REGISTRATION: www.trialregister.nl Identifier NTR116.

Olanzapine compared to quetiapine in adolescents with a first psychotic episode. [2009.07]
CONCLUSION: Olanzapine and quetiapine reduced psychotic symptoms in this adolescent sample. Patients on olanzapine gained significantly more weight. Side effects with both drugs seemed to be more prevalent than those reported in adult studies.

Extended release quetiapine fumarate monotherapy for major depressive disorder: results of a double-blind, randomized, placebo-controlled study. [2009.06]
CONCLUSION: In patients with MDD, quetiapine XR monotherapy (50/150/300 mg/day) is effective in reducing depressive symptoms, with improvement from Day 4 onwards. Safety and tolerability were consistent with the known profile of quetiapine.

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Clinical Trials Related to Seroquel XR (Quetiapine)

Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD) [Recruiting]
The Primary objective of this study is to evaluate Seroquel XR in the treatment of BPD. As

in many initial RCTs, the study will be of relatively short duration - 8 weeks - to assess

effectiveness and safety while maximizing retention. The specific aim is to determine if Seroquel XR is superior to placebo. The primary outcome measure will be a statistically significant difference between Seroquel XR compared to placebo on the ZAN-BPD, an objective rating scale that addresses the severity of DSM-IV symptoms of the illness. As there is the recent development of an extended release form of Seroquel (Seroquel XR) (Schulz et al. 2007), the new compound may offer several advantages in this study. Therefore, the hypothesis of this study is that both doses of Seroquel XR (see below) will be superior to placebo in an 8-week randomized trial as assessed by the ZAN-BPD.

To achieve the Primary Objective of this study, two doses of Seroquel XR will be tested -

150 mg/d and 300 mg/d. Thus, the study will be able to assess the effect of Seroquel XR compared to placebo and to explore a dose effect.

Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Occupancy of SEROQUEL [Recruiting]
The aim of this study is to relate pharmacokinetics of two different formulations of quetiapine to PET measured receptor occupancy in the brains of healthy subjects.

Efficacy of Seroquel Versus Seroquel With SSRI For Treatment of Depressive Disorder With Psychotic Features [Recruiting]
The purpose of this study is to compare the efficacy and tolerability of Seroquel monotherapy for the treatment of Major Depression with Psychotic features with Seroquel plus Selective Seratonin Reuptake Inhibitor.

High Dose of Quetiapine in Treating Subjects With Treatment Refractory Schizophrenia or Schizoaffective Disorder [Recruiting]
This study will investigate the safety and efficacy of quetiapine in sub-optimally responding patients with DSM-IV schizophrenia using a double blind, randomized 12-week trial comparing oral doses of 1200 mg/d to 600 mg/d of quetiapine.

Nis Register Study Comparing Seroquel and Seroquel Prolong [Recruiting]
The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are: 1. To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2. To collect information on duration and number of hospitalisation days 3. Change of GAF points

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Page last updated: 2009-11-19

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