ClinicalTrials.gov - Quetiapine for Mania In Preschool Children 4 to 6 Years of

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Thu, 18 May 2006 21:05:40 -0400

[sSRI-Research] ClinicalTrials.gov - Quetiapine for Mania In

Preschool Children 4 to 6 Years of Age With Bipolar Disorder

 

 

Here is the notice of the drug trial for the antipsychotic

***Quetiapine that has been a list topic for the past few days.

 

That this trial is targets toddlers is beyond comprehension. The

trial_/does not have to prove/_ either _/efficacy or safety/_ in this

groupof kids. The trial, alone, will _/extend the patent life of

this product for another six months/_. This six months is worth an

additional $1.4 billion is sales to AstraZeneca. The current patent

expires in 2011.**** **

 

*This substance was _/black boxed*/_ for the elderly recently, and

causes the problems that the atypicals have in general, including

diabetes, **and the ** _/all/_ **of **the other horrors of this class

of meds.

http://www.mentalhealth.com/drug/p30-q01.html

** **

**

Here is the black box warning for the elderly.

*

** Studies have shown that older adults with dementia

(significant loss of intellectual abilities, such

as memory, severe enough to affect social or occupational

functioning) who take antipsychotic

medications such as quetiapine to treat behavioral problems have an

increased chance of death.

Quetiapine is not approved by the FDA for use in the

treatment of behavioral disorders in older

adults with dementia.Talk to the doctor who prescribed this

medication, if you, a family member,

or someone you take care of is taking quetiapine to treat

behavioral problems associated with

dementia. For more information visit the FDA website:

http://www.fda.gov/cder

**

With a track record like this, they are using this stuff on developing

brains of four year olds???

 

Vince

**

 

 

http://www.clinicaltrials.gov/ct/show/NCT00181883?order=1

***

Quetiapine ** *(Seroquel -AstraZeneca

<http://en.wikipedia.org/wiki/AstraZeneca>) * ,**for Mania In

Preschool Children

_/4 to 6 Years of Age/_ With Bipolar Disorder

 

 

* *

 

**This study is currently recruiting patients.*

Verified by Massachusetts General Hospital March 2006*

 

* *

* *

* * * * * ** *

* * * * * **Sponsored by:* * *

*Massachusetts General Hospital* * *

* * * **Information provided by:* * *

*Massachusetts General Hospital* * *

* * * **ClinicalTrials.gov Identifier:* * *

*NCT00181883* * *

* * * *

 

 

 

** Purpose **

 

*This is an 8-week open-label study aimed at assessing the effectiveness

and tolerability of Quetiapine, in the treatment of preschool children

aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an

exploratory, pilot study, seeking to determine whether Quetiapine is

efficacious and well tolerated in the treatment of preschoolers with

pediatric bipolar and bipolar spectrum disorder in this age group. The

study results will be used to generate hypotheses for a larger

randomized controlled clinical trial with explicit hypotheses and

sufficient statistical power. *

* *

* * * * * **Condition * * * *Intervention* * * *Phase* * *

* * * **Bipolar Disorder

Mania

* * * * Drug: quetiapine (Seroquel)

* * * *Phase IV <http://www.clinicaltrials.gov/ct/info/phase>

* * *

* * * *

 

**

 

*MedlinePlus

<http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAMsoKSmw0tcvLy%2FXy8v\

J1cvLzNBLzy%2FTz01NycnMSy3IKS3WBwAKdDCLIwAAAA%3D%3D%0A & warn=false>

related

topics: Bipolar Disorder

<http://www.clinicaltrials.gov/ct/visit?uid=7a3H4sIAAAAAAAAAAXB2w2AMAgAwI3g3200N\

IWEVyjK%2Bt5xd16IMwOuBi4MOz60RSq%2BUt%2BDj2ToXSQn%0AilYBt%2BkPqtvpmTcAAAA%3D%0A & \

warn=false>

*

 

*Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled,

Single Group Assignment, Safety/Efficacy Study *

 

*Official Title: Open-Label Study of Quetiapine for Mania In Preschool

Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder*

 

*Further study details as provided by Massachusetts General Hospital:*

*Primary Outcomes: reductions in symptoms measured by; Young-Mania

Rating Scale (Y-MRS); Mania Symptom Checklist

Expected Total Enrollment: 20 *

 

*Study start: February 2005

*

 

* *

 

*S elroquil is a psychotropic agent that affects multiple neuro

transmitter receptors in the brain: serotonin 5HT1A and 5HT2, dopamine

D1 and D2, histamine H1 (IC50=30nM), and adrenergic receptors. *

 

* *

 

*This is an 8-week open-label study aimed at assessing the effectiveness

and tolerability of Quetiapine, in the treatment of preschool children

aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an

exploratory, pilot study, seeking to determine whether Quetiapine is

efficacious and well tolerated in the treatment of preschoolers with

pediatric bipolar and bipolar spectrum disorder in this age group. The

study results will be used to generate hypotheses for a larger

randomized controlled clinical trial with explicit hypotheses and

sufficient statistical power. *

 

* *

 

** Eligibility **

 

* Ages Eligible for Study: 4 Years - 6 Years, Genders Eligible for

Study: Both *

*Criteria*

* *

 

*Inclusion Criteria:*

 

* *

 

* *Male or female subjects, 4-6 years of age.*

* *Subjects must have a DSM-IV diagnosis of bipolar I, bipolar II

disorder or bipolar spectrum disorder and currently displaying

manic, hypomanic, or mixed symptoms (with or without psychotic

features) according to the DSM-IV based on clinical assessment and

confirmed by structured diagnostic interview (Kidd Schedule of

Affective Disorders and Schizophrenia Epidemiological Version).

Bipolar spectrum disorder (or sub-threshold bipolar disorder) is

operationalized as having severe mood disturbance, which meets

DSM-IV Criteria A for bipolar disorder but meet fewer elements in

criteria B (only require 2 items for elation category and 3 for

irritability). *

* *Subjects and their legal representative must have a level of

understanding sufficient to communicate intelligently with the

investigator and study coordinator, and to cooperate with all

tests and examinations required by the protocol. *

* *Subjects and their legal representative must be considered

reliable.*

* *Each subject and his/her authorized legal representative must

understand the nature of the study. The subject's authorized legal

representative must sign an informed consent document. *

* *Subjects must have an initial score on the Y-MRS total score of

at least 20.*

* *Subject must be able to participate in mandatory blood draws.*

* *Subjects with comorbid ADHD, ODD, CD, anxiety and depressive

disorders will be allowed to participate in the study provided

they do not meet for any of the exclusionary criteria. *

* *For concomitant stimulant therapy used to treat ADHD, subjects

must have been on a stable dose of the medication for 1 month

prior to study enrollment. The dose of the stimulant therapy will

not change throughout the duration of the study. *

 

* *

 

*Exclusion Criteria:*

 

* *

 

* *Investigator and his/her immediate family; defined as the

investigator's spouse, parent, child, grandparent, or grandchild.*

* *Serious, unstable illness including hepatic, renal,

gastroenterological, respiratory, cardiovascular (including

ischemic heart disease), endocrinologic, neurologic, immunologic,

or hematologic disease. *

* *Uncorrected hypothyroidism or hyperthyroidism.*

* *History of severe allergies or multiple adverse drug reactions.*

* *Non-febrile seizures without a clear and resolved etiology.*

* *Leukopenia or history of leukopenia without a clear and resolved

etiology.*

* *Judged clinically to be at serious suicidal risk.*

* *Any other concomitant medication with primarily central nervous

system activity other than specified in Concomitant Medication

portion of the protocol. *

* *A non-responder or a history of intolerance to an adequate trial

of Quetiapine(2 months or more at an adequate dose) as determined

by the clinician. *

* *Current diagnosis of schizophrenia.*

* *Non English speaking subjects will not be allowed into the study

for the following reasons: a) the assessment instruments are not

available and have not been adequately standardized in other

languages; b) our clinical trials facility is located in Cambridge

and not in the MGH main campus without the availability of

translators; c) psychiatric questionnaires and evaluations are

taxing and adding the complexity of a translator has the potential

to make the patient experience even more exhausting. *

 

* *

 

** Location and Contact Information **

 

* Please refer to this study by ClinicalTrials.gov identifier

NCT00181883 *

*Meghan Dougherty, BS 617 503-1051 mdougherty2

<mdougherty2?subject=NCT00181883,%202004-P-001509:%20-%20%20\

Quetiapine%20for%20Mania%20In%20Preschool%20Children%204%20to%206%20Years%20of%2\

0Age%20With%20Bipolar%20Disorder>

*

*

*Massachusetts*

Massachusetts General Hospital, Cambridge, Massachusetts,

02138, United States; Recruiting *

*Meghan Dougherty, BS 617-503-1051 mdougherty2

<mdougherty2?subject=NCT00181883,%202004-P-001509:%20-%20%20\

Quetiapine%20for%20Mania%20In%20Preschool%20Children%204%20to%206%20Years%20of%2\

0Age%20With%20Bipolar%20Disorder>

 

 

Megan Aleardi, BA 617 503-1405 maleardi

<maleardi?subject=NCT00181883,%202004-P-001509:%20-%20%20Que\

tiapine%20for%20Mania%20In%20Preschool%20Children%204%20to%206%20Years%20of%20Ag\

e%20With%20Bipolar%20Disorder>

 

 

Joseph Biederman, MD, Principal Investigator

*

**

*

*

* Study chairs or principal investigators *

*

Joseph Biederman, MD, Principal Investigator, Massachusetts General

Hospital *

 

** More Information **

 

* Study ID Numbers: 2004-P-001509

Last Updated: March 10, 2006

Record first received: September 13, 2005

ClinicalTrials.gov Identifier: NCT00181883

<http://ClinicalTrials.gov/show/NCT00181883>

Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on 2006-05-18 *

*

*