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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 (quetiapine) is not approved for the treatment of patients with Dementia-Related Psychosis.
Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of SEROQUEL or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)
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SEROQUEL SUMMARY
SEROQUEL®
(quetiapine fumarate)
TABLETS
SEROQUEL (quetiapine fumarate) is a psychotropic agent belonging to a new chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [
b,f
] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt.
SEROQUEL is indicated for the short-term treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex.
SEROQUEL is indicated for the treatment of schizophrenia.
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SEROQUEL NEWS HIGHLIGHTS Media Articles Related to Seroquel (Quetiapine)
Combined Data From Four Large-Scale Studies Demonstrate The Efficacy And Tolerability Of Seroquel In Bipolar Depression
Source: Bipolar News From Medical News Today [2009.05.25]
Results presented today at the 162nd American Psychiatric Association (APA) congress in San Francisco, CA, demonstrated the efficacy and tolerability of SEROQUEL® (quetiapine fumarate) for treating depressive episodes in bipolar disorder, including the difficult-to-treat bipolar II patient population.1,2 The data are from combined analyses of four large-scale clinical trials to examine SEROQUEL as a treatment for depressive episodes associated with bipolar I and II disorders.
For Bipolar Depression, Surveyed Experts Indicate That Current And Emerging Therapies Have No Advantage Over Seroquel In Decreasing The Syptoms
Source: Bipolar News From Medical News Today [2009.04.28]
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that surveyed psychiatrists identify a therapy's effect on decrease in severity of depressive symptoms as the attribute that most influences their prescribing decisions in bipolar depression.
FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
Source: MedicineNet Bipolar Disorder Specialty [2009.04.09]
Title: FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
Category: Health News
Created: 4/9/2009 2:00:00 AM
Last Editorial Review: 4/9/2009
Role of Seroquel in treating bipolar depression confirmed
Source: The Doctors Lounge - Psychiatry
Seroquel achieved a statistically significant reduction in levels of bipolar depression when compared with placebo.
New Research Under Way To Study Treatment For Older Adults With Bipolar Disorder
Source: Bipolar News From Medical News Today [2009.05.08]
Continuing their groundbreaking research into the treatment of mood disorders in older adults, psychiatrists at the Weill Cornell Institute of Geriatric Psychiatry at the NewYork-Presbyterian Hospital/Westchester Division in White Plains will begin new studies on the effects of quetiapine (Seroquel: Astra Zeneca) and lamotrigine (Lamictal: GlaxoSmithKline).
Published Studies Related to Seroquel (Quetiapine)
Quetiapine monotherapy in the treatment of depressive episodes of bipolar I and II disorder: Improvements in quality of life and quality of sleep. [2008.12]
INTRODUCTION: The depressive symptoms of bipolar disorder impact health-related quality of life, quality of sleep and functioning. The BOLDER I and II trials demonstrated that quetiapine [generic for Seroquel] significantly improves depressive symptoms in patients with acute bipolar depression. Post-hoc analysis of the BOLDER I and II data permits a detailed investigation of the effects of quetiapine on these other measures in this patient population... CONCLUSIONS: Quetiapine monotherapy is effective in improving impairment in important aspects of life that accompany improvements in depressive symptoms in patients with acute bipolar depression.
Dosing quetiapine in drug-naive first-episode psychosis: A controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years. [2008.11.18]
CONCLUSION: Our study in acutely ill drug-naive first-episode psychosis patients suggests that quetiapine [generic for Seroquel] is a safe and well-tolerated anti-psychotic medication. In contrast to multiepisode patients, dosing should be more conservative in untreated new-onset cases. An initial dose of 250 to 300 mg/day of quetiapine is proposed as a primary target dose in drug-naive first-episode psychosis patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00449397. (c) Copyright 2008 Physicians Postgraduate Press, Inc.
Quetiapine addition to serotonin reuptake inhibitors in patients with severe obsessive-compulsive disorder: a double-blind, randomized, placebo-controlled study. [2008.10]
CONCLUSIONS: In this study, augmentation of SRI treatment with quetiapine [generic for Seroquel] in severe OCD had no additional effect.
Efficacy of quetiapine monotherapy in rapid-cycling bipolar disorder in comparison with sodium valproate. [2008.10]
BACKGROUND: Rapid-cycling bipolar disorder is often characterized by a lack of response to psychopharmacological treatment, and a standard therapy has not been developed yet. The aim of this study was to examine the long-term efficacy and safety of a monotherapy with quetiapine [generic for Seroquel] or sodium valproate (VPA) in patients with rapid-cycling bipolar disorder... CONCLUSIONS: In this study, quetiapine was more effective than VPA on the number of depressive days and similar to VPA in the treatment of manic symptoms. Quetiapine was associated with a greater incidence of side effects, particularly orthostatic dysregulation, sedation, and weight gain.
A randomized, double-blind, and placebo-controlled trial of quetiapine augmentation of fluoxetine in major depressive disorder. [2008.09]
The objective of this study was to investigate whether quetiapine [generic for Seroquel], when compared with placebo, can speed the onset of action and improve the quality of response to fluoxetine treatment in patients suffering from major depressive disorder. A total of 114 patients with major depressive disorder were enrolled in an 8-week treatment study... The combination of quetiapine and fluoxetine, however, improved sleep over fluoxetine alone over the first few weeks of treatment.
Clinical Trials Related to Seroquel (Quetiapine)
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive Disorders [Completed]
The purpose of this study is to demonstrate superior efficacy of Quetiapine fumarate
sustained release (SEROQUEL) compared with placebo when used as a mono-therapy in the
treatment of Major Depressive Disorders
Seroquel- Agitation Associated With Dementia [Completed]
The purpose of this study is to determine how safe and effective Seroquel (quetiapine
fumarate) is compared to placebo (a non-drug tablet) for a period of up to 10 weeks in the
treatment of agitation symptoms in nursing home or assisted care residents.
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo [Completed]
This study is being carried out to see if quetiapine (Seroquel) is effective in preventing
patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it
compares with non-active treatment.
Phase 3 /Seroquel SR Acute Mania Monotherapy - US [Completed]
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.
Phase III/Seroquel SR Bipolar Depression Monotherapy - US [Completed]
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 weeks.
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SEROQUEL PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Seroquel has an overall score of 6.50. The effectiveness score is 7.67 and the side effect score is 5.67. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Seroquel review by 45 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | schizo-affective disorder |
| Dosage & duration: | | 200mg taken once daily at bedtime for the period of 2 yrs |
| Other conditions: | | high cholesterol |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | A very good nights sleep is one of the benefits, found out that the sedative effects are actually increased in the lower doses. I lowered my dosage and live the sound sleep. it knocked out my delusions and hallucinations, hopefully for good. |
| Side effects: | | weight gain is the worst side effect, but a small price to pay for sanity. |
| Comments: | | I actually ended up with motion disorders from all the other meds, the worst one being parkinsons for over a year. I had to take parkinsons drugs. It was so scary drooling all the time and looking stone faced, no expression. I dont feel any signs of this with the seroquel. |
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| | Seroquel review by 39 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Anxiety |
| Dosage & duration: | | 12.5 mg taken 1 per day for the period of 3 weeks |
| Other conditions: | | None |
| Other drugs taken: | | Lamictal | | |
Reported Results |
| Benefits: | | Helped relieve anxiety |
| Side effects: | | Dizziness, moodiness, anger and agitation |
| Comments: | | At first the medication seemed to work wonders in a very short period of time (a few days). After about a week I began to get extremely moody - crying a lot, getting very angry and agitated. It appeared that once the medication started building up in my system the side effects became worse and worse. It was not worth it and I quit the medication within a few weeks. |
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| | Seroquel review by 27 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar disorder, hypomania. |
| Dosage & duration: | | 100 mg taken 1 for the period of 5 days |
| Other conditions: | | None |
| Other drugs taken: | | Lithium Carbonate, Zetran, | | |
Reported Results |
| Benefits: | | None. I only took them for a couple of days, but had to stop because of the side-effects. |
| Side effects: | | The biggest side-effect was that it made me experience shock-waves through my head and sometimes even my body, just like if someone would have turned on and off a lamp very quickly. That side-effect ended the same time I stopped taking Seroquel. The other one was that everything started to smell and taste very bad. It´s hard to explain exactly how, but it was a mix of vodka and mould. After I stopped taking the medication it took 2 weeks for the taste/smell-problem to disapear. |
| Comments: | | I was prescribed with Seroquel after I was released from hospital after a period of deep depression to help me to sleep better and stop me from becoming hypomanic. |
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Page last updated: 2009-05-25
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