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Seroquel (Quetiapine Fumarate) - Summary


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)



(quetiapine fumarate)

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.

See all Seroquel indications & dosage >>


Media Articles Related to Seroquel (Quetiapine)

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.

Help for schizophrenia patients and their caregivers
Source: Caregivers / Homecare News From Medical News Today [2014.11.14]
University of Miami researchers are developing a novel, culturally informed, family therapy for schizophreniaResearchers at the University of Miami (UM) have developed a family-focused...

New real-world data highlight health and financial impact of caring for an adult with schizophrenia
Source: Caregivers / Homecare News From Medical News Today [2014.11.12]
Data presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress, Amsterdam, The Netherlands, reveal that caregivers of adults with...

Robot may explain some symptoms in schizophrenia and other neurological conditions
Source: Epilepsy News From Medical News Today [2014.11.10]
People don't really tend to see ghosts or guardian angels as much as "feel" them, and now researchers reporting in the Cell Press journal Current Biology think they know where that "feeling of a...

A fifth of schizophrenia cases 'may be attributable to T. gondii infection'
Source: Schizophrenia News From Medical News Today [2014.11.02]
A researcher from the University of Pennsylvania calculates that Toxoplasma gondii - a parasite that causes toxoplasmosis - may be involved in more than 20% of schizophrenia cases.

more news >>

Published Studies Related to Seroquel (Quetiapine)

Quetiapine: a pharmacoeconomic review of its use in bipolar disorder. [2012]
This article briefly summarizes the burden of bipolar disorder and the clinical profile of quetiapine (Seroquel®) in the management of bipolar disorder, followed by a detailed review of pharmacoeconomic analyses...

A double-blind, placebo-controlled trial to assess the efficacy of quetiapine fumarate XR in very heavy-drinking alcohol-dependent patients. [2012]
very heavy drinkers... CONCLUSIONS: This multisite clinical trial showed no efficacy for quetiapine

A double-blind, randomized, controlled trial of fluoxetine plus quetiapine or clomipramine versus fluoxetine plus placebo for obsessive-compulsive disorder. [2011.12]
Obsessive-compulsive disorder patients who do not improve sufficiently after treatment with a selective serotonin reuptake inhibitor might improve further if other drugs were added to the treatment regimen... However, the period of monotherapy with the maximum dose of fluoxetine should be extended before a combination treatment strategy is applied.

Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. [2011.11]
BACKGROUND: Bipolar disorder, a highly recurrent and chronic condition, often necessitates periods of hospitalization and requires lifelong treatment with medication. It is characterized by alternating episodes of mania and depression. Given the severity of mania, physicians must be able to control symptoms rapidly. OBJECTIVE: The purpose of this pivotal, Phase III trial was to evaluate the efficacy and tolerability of once-daily extended-release quetiapine fumarate (quetiapine XR) monotherapy in improving manic symptoms in patients with bipolar I disorder... CONCLUSION: This 3-week trial suggests that quetiapine XR (400-800 mg) once-daily monotherapy is efficacious (from day 4) and generally well tolerated in patients with manic or mixed episodes of bipolar I disorder. ClinicalTrials.gov identifier: NCT00422123. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (trial 144: a randomized controlled study). [2011.11]
CONCLUSIONS: In patients stabilized during acute quetiapine treatment, continuation of quetiapine significantly increased time to recurrence of any mood, manic, or depressive event compared with switching to placebo. Switching to lithium was also more effective than placebo for the prevention of manic and depressive events. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00314184. (c) Copyright 2011 Physicians Postgraduate Press, Inc.

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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.

more trials >>

Reports of Suspected Seroquel (Quetiapine) Side Effects

Drug Dose Omission (1904)Insomnia (1383)OFF Label USE (1165)Malaise (739)Intentional Drug Misuse (531)Feeling Abnormal (471)Depression (463)Anxiety (423)Somnolence (406)Weight Increased (389)more >>


Based on a total of 32 ratings/reviews, Seroquel has an overall score of 6. The effectiveness score is 7.69 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

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.


Seroquel review by 38 year old male patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   bipolar mania
Dosage & duration:   50 mg taken as needed for the period of 2 years
Other conditions:   bipolar depression, anxiety
Other drugs taken:   lamictal
Reported Results
Benefits:   I am using this on an as needed basis. I only take it a couple times a month, which is why 50mg still works for me. I may have to go to 100mg though. If I have been up for 20-25 hours straight and if I am still "bouncing off the walls" (manic), then this is great stuff to have. For as needed manic episodes and severe insomnia--this is great stuff.
Side effects:   Biggest problem is the LONG half-half. After sleeping for over 10 hours, I spend the next 6 hours after I wake up foggy-headed and VERY lethargic. After this I usually feel good again.
Comments:   I mainly suffer from severe depression and anxiety but after a couple weeks of this I sometimes suffer from 2 or 3 days of mania.


Seroquel review by 20 year old female patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   Bi-polar, depression
Dosage & duration:   100mg taken once a day for the period of 5 months
Other conditions:   N/A
Other drugs taken:   N/A
Reported Results
Benefits:   For the first two months it seemed to help, even though the first night on it was the scariest feeling ever. It made me motivated for those two months..
Side effects:   I ended up with severe anxiety and paranoia after taking this pill, something I had never had before taking it. After the initial 2 month honeymoon period, I felt like I was a zombie..I literally felt nothing at all, and if I was lucky enough to feel something, it would be anxiety. I'm STILL trying to reverse the effects of this drug, and I've been off it for over 3 years now. I would not recommend this to ANYONE, unless you're willing to ruin your personality & life for the sake of a two month good spell.
Comments:   .

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Page last updated: 2014-11-14

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