Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512070
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-27
First Post:
2007-08-03
Brief Title:
Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Melatonin Metabolism Abnormality in Patients With Schizophrenia or Schizoaffective Disorder Treated With Olanzapine and Melatonin Dose Finding for the Correction of the Metabolic Abnormality
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
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:
Atypical antipsychotic medications such as olanzapine cause metabolic side effects including weight gain extra fat around the middle of the body high blood sugar and high cholesterol One of the mechanisms by which these medications may cause these effects is by reducing plasma melatonin This study is a pilot project to evaluate 1 the effect of olanzapine on melatonin secretion levels and 2 the effect of melatonin on olanzapine-induced changes in melatonin secretion in patients with schizophrenia schizoaffective or bipolar disorder
Detailed Description:
To investigate the relationship between olanzapine melatonin and metabolic functioning this pilot study is evaluating 20 patients with schizophrenia schizoaffective disorder or bipolar disorder over 15 weeks under three experimental conditions 1 baseline two weeks treatment with already established antipsychotic medication other than olanzapine or clozapine 2 six weeks treatment with olanzapine only and 3 six weeks treatment with olanzapine and melatonin Half of the patients will receive 03 mg of oral melatonin and half will receive 30 mg of melatonin Nocturnal melatonin production as estimated by assay of urinary 6-sulfatoxymelatoninaMT6s adjusted for creatinine will be measured weekly In addition weekly measurements of weight and other metabolic indices including waist and hip measurements fasting glucose serum insulin cholesterol triglycerides and leptin will be taken It is anticipated that there will be an olanzapine-induced decrease in melatonin production Furthermore it is expected that the decrease in melatonin production associated with olanzapine treatment will be reversed by administration of melatonin with olanzapine
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