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Seroquel (Quetiapine Fumarate) - Summary



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 patients under ten years of age [see Warnings and Precautions ].



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


SEROQUEL is indicated for the treatment of schizophrenia. The efficacy of SEROQUEL in schizophrenia was established in three 6-week trials in adults and one 6–week trial in adolescents (13–17 years). The effectiveness of SEROQUEL for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see Clinical Studies ].

Bipolar Disorder

SEROQUEL is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10-17 years) [ see Clinical Studies ].

SEROQUEL is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies ].

SEROQUEL is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of SEROQUEL as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [ see Clinical Studies ].

Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder

Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.

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.

Cognitive Therapy May Reduce Insomnia in Patients With Schizophrenia
Source: Medscape Medical News Headlines [2015.10.02]
Cognitive behavioral therapy (CBT) may reduce insomnia in patients with persistent delusions or hallucinations, a new study suggests.
Reuters Health Information

ERs Often 'Safety Net' Care for People With Schizophrenia: CDC
Source: MedicineNet Schizophrenia Specialty [2015.09.24]
Title: ERs Often 'Safety Net' Care for People With Schizophrenia: CDC
Category: Health News
Created: 9/23/2015 12:00:00 AM
Last Editorial Review: 9/24/2015 12:00:00 AM

Repairing the brain - Two genes unlock potential for treatment of schizophrenia
Source: Schizophrenia News From Medical News Today [2015.09.21]
Research led by scientists from Duke-NUS Graduate Medical School Singapore (Duke-NUS) has linked the abnormal behaviour of two genes (BDNF and DTNBP1) to the underlying cause of schizophrenia.

Vraylar Approved for Schizophrenia, Bipolar Disorder
Source: MedicineNet Bipolar Disorder Specialty [2015.09.21]
Title: Vraylar Approved for Schizophrenia, Bipolar Disorder
Category: Health News
Created: 9/18/2015 12:00:00 AM
Last Editorial Review: 9/21/2015 12:00:00 AM

more news >>

Published Studies Related to Seroquel (Quetiapine)

Predicting 1-year risk for relapse in patients who have discontinued or continued quetiapine after remission from first-episode psychosis. [2013]
CONCLUSION: Different predictors of relapse were identified for first episode

Quetiapine versus haloperidol in the treatment of delirium: a double-blind, randomized, controlled trial. [2013]
delirious behavior... CONCLUSION: Low-dose quetiapine and haloperidol may be equally effective and safe

Annual cost of relapses and relapse-related hospitalizations in adults with schizophrenia: results from a 12-month, double-blind, comparative study of lurasidone vs quetiapine extended-release. [2013]
quetiapine extended-release (XR)... CONCLUSION: Adults treated for schizophrenia with lurasidone are predicted to

Randomized, placebo-controlled trial of quetiapine XR and divalproex ER monotherapies in the treatment of the anxious bipolar patient. [2013]
are seldom the focus of bipolar treatment studies... CONCLUSIONS: Quetiapine XR in a dose range of 50-300 mg/day appears to reduce

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...

more studies >>

Clinical Trials Related to Seroquel (Quetiapine)

Seroquel Extended Release (XR) for the Management of Borderline Personality Disorder (BPD) [Active, not 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.

Depakote Extended Release (ER) Versus Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia [Completed]
The primary objective of the study is to assess the relative efficacy of Depakote ER and Seroquel for agitated behaviors among veterans with a dementia diagnosis residing in a Department of Veterans Affairs (VA) nursing home care unit (NHCU). The secondary objective of the study is to assess the relative tolerability of Depakote ER and Seroquel in this population. The primary hypothesis is that agitated dementia patients will demonstrate a significantly greater reduction in Cohen-Mansfield Agitation Inventory (CMAI) scores while treated with Depakote ER compared to treatment with Seroquel.

Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms [Terminated]
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 Serotonin Reuptake Inhibitor.

Efficacy and Safety of Utapine vs. Seroquel in Patients With Bipolar Mania [Recruiting]
The goal of this research is to evaluate the safety as well as effectiveness of Utapine and Seroquel in bipolar I disorder patients.

Pharmacokinetic Study Comparing Topical, Rectal, and Oral Quetiapine [Active, not recruiting]
Quetiapine, a second generation antipsychotic, is only available as oral tablets. However, topical and rectal formulations have been produced in compounding pharmacies. There is no data available suggesting that topical or rectal formulations provide serum levels similar to oral medication. In the clinical setting, when oral administration of quetiapine is not possible (for example, when a patient is extremely ill physically or mentally or both), clinicians and pharmacists have collaborated in such cases and have at times had to administer quetiapine compounded in other dosage formulations such as rectal or topical formulations. Despite clinical effectiveness of these "other" formulations, there are no available studies that have investigated blood levels of the drug other than the oral form. The investigators are therefore designing this pharmacokinetic study to evaluate the the systemic absorption of quetiapine in oral, rectal and topical formulations. If the investigators are able to demonstrate detectable levels from rectal and topical quetiapine formulations compared to the oral form, this knowledge will enhance clinical psychiatric practice by providing a more broad route of administration for quetiapine which is a commonly used drug for psychiatric symptoms.

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: 2015-10-02

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