Selling Our Children to the Pharmaceutical Industry - PBS reports
Have we sold our kids to the pharmaceutical Industry? This PBS report appears to be evidence that foster kids have been not just used, but abused as cash cows for exactly this purpose...corrupted doctors who have forgotten they took an oath to do no harm, not to profit as much as possible. Medicine has lost it's way, and they are not going to change direction until we make them change direction. Watch this video and then read this supposed
Yes, you could have guessed that it was directed out of Massachusetts General Hospital ( Janet Wozniak, MD ). Most in the know consider this Harvard University affiliated Hospital the center and birth place of the "BIPOLAR CHILD" Myth.
Please keep in mind as you read this study that there is no stated criteria for preschool bipolar disorder in the DSM-IV. The well funded Pharmaceutical Industry shill doctors @ Harvard created this criteria out of thin air to get drug approval from the FDA. Then using this
I have a really hard time following this sick and twisted
Watch the full episode. See more Need To Know.
http://clinicaltrials.gov/pediatric+quetiapine
Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder
This study has been completed.
Purpose
Eligibility
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.
Official Title: Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder
Primary Outcome Measures:
- reductions in symptoms measured by [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Young-Mania Rating Scale (Y-MRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Mania Symptom Checklist [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
Study Completion Date: | April 2009 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description: - Drug: quetiapine (Seroquel)
2.5 - 5.0mg/kg PO BID quetiapine
Seroquel is a psychotropic agent that affects multiple neurotransmitter 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.
Ages Eligible for Study: | 4 Years to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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