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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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NEWS HIGHLIGHTSMedia Articles Related to Seroquel (Quetiapine)
FDA Panel Snubs Seroquel as 1st Choice Depression Treatment
Source: MedicineNet clozapine 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.
Exercise Builds Brain Volume in Schizophrenia (CME/CE)
Source: MedPage Today Psychiatry [2010.02.01]
Three months of aerobic exercise significantly increased the volume of the hippocampus in patients with chronic schizophrenia, researchers said.
Can fish oil help guard against schizophrenia? (Reuters)
Source: Y! Health News Search RSS Feed [2010.02.01]
Reuters - Taking fish oil may help prevent full-blown psychotic illness in at-risk adolescents and young adults, a study released today hints.
Early Intervention Could Prevent Schizophrenia
Source: Schizophrenia News From Medical News Today [2010.01.29]
The onset of schizophrenia is not easy to predict. Although it is associated with as many as 14 genes in the human genome, the prior presence of schizophrenia in the family is not enough to determine whether one will succumb to the mind-altering condition. The disease also has a significant environmental link. According to Prof...
Published Studies Related to Seroquel (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.
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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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 13 ratings/reviews, Seroquel has an overall score of 6.23. The effectiveness score is 8 and the side effect score is 5.69. 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 40 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Sleeplessness and restless mind at night |
| Dosage & duration: | | 40 milligrams (dosage frequency: daily, right before bed) for the period of 3 weeks |
| Other conditions: | | depression |
| Other drugs taken: | | Prozac | | |
Reported Results |
| Benefits: | | Calmed racing mind (caused by stress and depression) and allowed a restful night's sleep. Cleared the mind completely, did not dream at night, and did not wake during the night. |
| Side effects: | | Difficulty waking up. Grogginess during the entire morning. Inability to clearly focus throughout the day, due to the grogginess. Increased frequency of migraines, in a person already subject to migraines. |
| Comments: | | Prescribed to be taken nightly as needed. Originally prescribed 20 mg, increasing to 40 mg, and potentially increasing to 60 mg if needed for a 135 lb woman. Intended to be taken for a few months, but due to grogginess and difficulty focusing, stopped using it after 3 weeks. |
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| | Seroquel review by 45 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar |
| Dosage & duration: | | 25 - 200 mg taken daily for the period of 3 months |
| Other conditions: | | none |
| Other drugs taken: | | lithium, tegretol | | |
Reported Results |
| Benefits: | | I slept wonderfully well. |
| Side effects: | | Staggering and running into objects in the house when I got up, wanting to sleep 18 hours a day, weight gain of 30 lbs in the short time I took it confusion, clouded thinking, forgetfullnes which increased the longer I was on the medication. The confusion, being in a daze part was the worst. I couldn't remember where my Doctor's office was located and I live in a small town and less that two miles from his office. My thinking cleared up as soon as I stopped taking the Seroquel. This was an awful medication for me. |
| Comments: | | I took 200 mg at night at first. This was then decreased to 25 mg at night to help me sleep. |
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Page last updated: 2010-02-01
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