Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224822
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
2005-09-21
Brief Title:
The Effects of Aripiprazole on Patients With Metabolic Syndrome
Sponsor:
New Mexico VA Healthcare System
Organization:
New Mexico VA Healthcare System
Study Overview
Official Title:
The Effects of Aripiprazole on Patients With Metabolic Syndrome An Open-Label Trial
Status:
COMPLETED
Status Verified Date:
2007-09
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 primary goal of this study is to assess the effect of aripiprazole on patients who developed metabolic syndrome while taking other second generation antipsychotic medications
Detailed Description:
Schizophrenia schizoaffective disorder and bipolar disorder are severe and disabling disorders associated with marked social or occupational dysfunction tenfold suicidal risk intensive healthcare resource utilization and poor prognosis Atypical antipsychotics developed in the last decade are proving beneficial to a subset of patients These agents share a reduced risk for EPS and tardive dyskinesia in comparison with first generation antipsychotics They also appear to improve negative cognitive and depressive symptoms while being at least as efficacious as first generation typical drugs in controlling positive symptoms of schizophrenia and schizoaffective disorder Unfortunately during the late 1990s case reports and studies began to document a number of adverse events associated with the use of most second generation antipsychotics such as weight gain hyperlipidemia and hyperglycemia subsumed under the name metabolic syndrome Aripiprazole has a unique pharmacological mechanism making this drug the ideal medication for treatment to patients who experience metabolic syndrome from other second generation antipsychotics In numerous pervious trials it has been demonstrated that aripiprazole is a safe and effective treatment for schizophrenia schizoaffective disorder and bipolar disorder and that it may actually reduce plasma glucose levels and improve lipid profiles lowering the risk for cardiovascular disease and or diabetes Thirty patients with Diagnostic and Statistical Manual of Mental Disorders Fourth Edition DSM-IV diagnosis of schizophrenia schizoaffective disorder or bipolar disorder who have experienced a 10 pound increase in weight while on a second generation antipsychotic or hyperlipidemia or hyperglycemia will switch to aripiprazole and be monitored for any improvement in BMI lipids and glucose
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 |
|---|---|---|---|
| BRINM 170 | None | None | None |