Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480168
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2007-05-25
Brief Title:
A Prospective Study to Assess Metabolic Changes in Children and Adolescents Treated With Atypical Antipsychotics
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
A Prospective Study to Assess Metabolic Changes in Children and Adolescents Aged 6-18 Treated With Atypical Antipsychotics
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to observe patients aged 6-18 with various psychiatric diagnosis being treated with drugs called atypical antipsychotics to determine the effects of the drugs on growth weight gain and laboratory tests
Detailed Description:
Introduction Antipsychotics have been used for many years to treat serious mental illnesses like schizophrenia and bipolar illness manic depression These older drugs carry a higher risk of side effects like shaking stiffness restlessness or uncontrolled movements They may occur when the drugs are first taken or later after years of use Newer drugs called atypical antipsychotics ATAs are much less likely to cause these problems Their lack of these side effects and greater safety have led doctors to use them for other diseases in both adults and younger patients They have proved to be helpful in aggression impulsiveness anxiety and mood swings Unfortunately a number of other side effects such as weight gain increased rates of diabetes and increases in cholesterol have also been identified While a lot of current research into these side effects has been done in adults there have been few studies with younger patients The research so far has been brief and involved small numbers This is especially important in this young and potentially vulnerable group of patients
Study Methods This research will study children and teens aged 6 to 18 who are being treated with the newer drugs for the first time If agreeable to the patients and their parents or guardians their doctors will prescribe one of the newer drugs and will measure the effects if any on weight blood sugar cholesterol as well as the improvement in their condition Weight height and blood work will be done before the drug is started and 6 and 12 months after they have been on it comparing the results with their original values The doctor the patient and the parent or guardian will rate the patients condition at these times as well to evaluate their improvement
Study Methods This research will study children and teens aged 6 to 18 who are being treated with the newer drugs for the first time If agreeable to the patients and their parents or guardians their doctors will prescribe one of the newer drugs and will measure the effects if any on weight blood sugar cholesterol as well as the improvement in their condition Weight height and blood work will be done before the drug is started and 6 and 12 months after they have been on it comparing the results with their original values The doctor the patient and the parent or guardian will rate the patients condition at these times as well to evaluate their improvement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11172 | OTHER | REB | None |