Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00191828
Status:
COMPLETED
Last Update Posted:
2007-01-26
First Post:
2005-09-12
Brief Title:
A Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A ProspectiveParallel Study on Induced Weight Gain During Atypical Antipsychotic Treatment and Its Management With Psychoeducational Programme
Status:
COMPLETED
Status Verified Date:
2007-01
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:
Olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode
Olanzapine is among the many antipsychotic agents associated with weight gain The mechanism for antipsychotic drug-related weight gain is not known although antagonism of serotonin receptors especially the 5HT2C and histamine receptors has been hypothesized
The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment
Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity
This is a phase IV randomised parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy which have shown an increase of BMI 7 from the beginning of antipsychotic treatment assessed during the routine visits For the first 12 weeks of the trial approximately 60 outpatients enrolled in one site during a period of one year will be randomised in a 11 ratio into 2 treatment groups olanzapine psychoeducational programme or olanzapine alone In the following 12 weeks of the study all patients undergo the psychoeducational programme The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI
Olanzapine is among the many antipsychotic agents associated with weight gain The mechanism for antipsychotic drug-related weight gain is not known although antagonism of serotonin receptors especially the 5HT2C and histamine receptors has been hypothesized
The purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment
Interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity
This is a phase IV randomised parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy which have shown an increase of BMI 7 from the beginning of antipsychotic treatment assessed during the routine visits For the first 12 weeks of the trial approximately 60 outpatients enrolled in one site during a period of one year will be randomised in a 11 ratio into 2 treatment groups olanzapine psychoeducational programme or olanzapine alone In the following 12 weeks of the study all patients undergo the psychoeducational programme The efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and BMI
Detailed Description:
None
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 |
|---|---|---|---|
| F1D-IT-HGLE | None | None | None |