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.
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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 HIGHLIGHTSMedia Articles Related to Seroquel XR (Quetiapine)
Schizophrenia Quiz: What is Schizophrenia?
Source: MedicineNet Schizophrenia Specialty [2017.09.19]
Title: Schizophrenia Quiz: What is Schizophrenia?
Category: MedicineNet Quiz
Created: 1/26/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:20:02 PM
Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.09.08]
Title: Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia
Category: Health News
Created: 9/7/2017 12:00:00 AM
Last Editorial Review: 9/8/2017 12:00:00 AM
'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.06.07]
Title: 'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia
Category: Health News
Created: 6/6/2017 12:00:00 AM
Last Editorial Review: 6/7/2017 12:00:00 AM
Bipolar Disorder vs. Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.05.18]
Title: Bipolar Disorder vs. Schizophrenia
Category: Diseases and Conditions
Created: 5/18/2017 12:00:00 AM
Last Editorial Review: 5/18/2017 12:00:00 AM
Schizophrenia
Source: MedicineNet Electroconvulsive Therapy Specialty [2016.10.24]
Title: Schizophrenia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 10/24/2016 12:00:00 AM
Published Studies Related to Seroquel XR (Quetiapine)
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
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
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
Clinical Trials Related to Seroquel XR (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.
Reports of Suspected Seroquel XR (Quetiapine) Side Effects
Drug Dose Omission (806),
Insomnia (469),
OFF Label USE (351),
Malaise (297),
Intentional Drug Misuse (209),
Depression (171),
Feeling Abnormal (167),
Anxiety (153),
Somnolence (136),
Bipolar Disorder (135), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 4 ratings/reviews, Seroquel XR has an overall score of 9. The effectiveness score is 9.50 and the side effect score is 6.50. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Seroquel XR review by 36 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar disorder |
| Dosage & duration: | | 400mg taken once a night for the period of since oct of 2009 |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | Adderallxr,trazadone,cymbalta,restirol | | |
Reported Results |
| Benefits: | | My treatment was good after I was hospitalized for deppression thay started me on Seroquel and I was getting better I started on it in oct 09 |
| Side effects: | | there was no side effects I took it at night |
| Comments: | | My mood changed a lot I went to in hospital therpay for 3mos they tried differnt drugs but seroquel changed alot it cost a lot $411 for 30 pills but it worth it |
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| | Seroquel XR review by 23 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar II |
| Dosage & duration: | | 200mg taken daily for the period of 10 months |
| Other conditions: | | none |
| Other drugs taken: | | LEXAPRO, 10mg | | |
Reported Results |
| Benefits: | | I was diagnosed with Bipolar II disorder in February of 2009. I found that my manic states led to very erratic and inconsistent behavior. I also found the depressive lows to be particularly difficult to manage.
In November 2009 I was prescribed SEROQUEL by a Urgent Care Physician. Immediately I found its calming effects to be extremely relieving to my mania. I did, however, find it difficult to maintain a functioning state due to its sedating effects. I then switched to SEROQUEL XR and found a much more successful experience. I was initially given 400mg SEROQUEL XR paired with 10mg LEXAPRO. While initially a good way to stop the mania, I found 400mg to be too much to function on. I decided to halve my SEROQUEL XR dose to 200mg continuing to take 10mg of LEXAPRO. This combo has been great and I am so much calmer and feel way more in control of my life. I do, however, find the sedating effects to be difficult upon awaking in the morning. I try to offset this by ensuring that I receive a full 8-10 hour rest after administering a dosage. I would highly recommend this combo to anyone that is having difficulty finding a mental balance between dark and light. This year of treatment has allowed me to find a calm that I have never quite experienced beforehand.
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| Side effects: | | I found that despite the great benefits mentally, the physical side effects are a fair trade.
I was about 115 lbs when I started this drug 10 months ago. Today I way about 147lbs. That's definitely a 37 pound gain.
Additionally, I always prided myself on my enormous amount of energy. After taking this drug I am extremely lethargic in the hours after taking it (bedtime) and the morning hours. |
| Comments: | | I take 200mg of SEROQUEL XR and 10mg of LEXAPRO nightly. |
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| | Seroquel XR review by 23 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Bipolar II |
| Dosage & duration: | | 200mg taken daily for the period of 10 months |
| Other conditions: | | none |
| Other drugs taken: | | LEXAPRO, 10mg | | |
Reported Results |
| Benefits: | | I was diagnosed with Bipolar II disorder in February of 2009. I found that my manic states led to very erratic and inconsistent behavior. I also found the depressive lows to be particularly difficult to manage.
In November 2009 I was prescribed SEROQUEL by a Urgent Care Physician. Immediately I found its calming effects to be extremely relieving to my mania. I did, however, find it difficult to maintain a functioning state due to its sedating effects. I then switched to SEROQUEL XR and found a much more successful experience. I was initially given 400mg SEROQUEL XR paired with 10mg LEXAPRO. While initially a good way to stop the mania, I found 400mg to be too much to function on. I decided to halve my SEROQUEL XR dose to 200mg continuing to take 10mg of LEXAPRO. This combo has been great and I am so much calmer and feel way more in control of my life. I do, however, find the sedating effects to be difficult upon awaking in the morning. I try to offset this by ensuring that I receive a full 8-10 hour rest after administering a dosage. I would highly recommend this combo to anyone that is having difficulty finding a mental balance between dark and light. This year of treatment has allowed me to find a calm that I have never quite experienced beforehand.
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| Side effects: | | I found that despite the great benefits mentally, the physical side effects are a fair trade.
I was about 115 lbs when I started this drug 10 months ago. Today I way about 147lbs. That's definitely a 37 pound gain.
Additionally, I always prided myself on my enormous amount of energy. After taking this drug I am extremely lethargic in the hours after taking it (bedtime) and the morning hours. |
| Comments: | | I take 200mg of SEROQUEL XR and 10mg of LEXAPRO nightly. |
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Page last updated: 2017-09-19
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