Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363376
Status:
COMPLETED
Last Update Posted:
2012-04-13
First Post:
2006-08-09
Brief Title:
A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
Sponsor:
Lindner Center of HOPE
Organization:
Lindner Center of HOPE
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
Status:
COMPLETED
Status Verified Date:
2012-04
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 specific aim of this study is to evaluate the efficacy tolerability and safety of zonisamide therapy in the prevention of weight gain associated with olanzapine treatment for psychotic or bipolar disorders
Detailed Description:
This is a single center 16-week randomized double-blind placebo-controlled parallel group flexible-dose study in 60 outpatients with schizophrenia schizoaffective disorder schizophreniform disorder delusional disorder psychotic disorder NOS or bipolar disorder types I II or NOS by DSM-IV-TR criteria43 with a BMI 22 for whom treatment with olanzapine 5-20 mgday would be appropriate as monotherapy or adjunctive therapy Subjects who meet entry criteria will be randomized to treatment with olanzapine plus zonisamide or olanzapine plus placebo All subjects will receive Personal Wellness Solution Counseling httpwwwzyprexacomhcphcp_patient_c_solutions_printjsp Both before and after randomization to zonisamide or placebo patients will not be permitted to have any other major psychotropic medications antipsychotics mood stabilizers antidepressants or anxiolytics added to their medication regimens The primary outcome measure will be change in weight Secondary outcome measures will include the Young Mania Rating Scale YMRS44 the Inventory for Depressive Symptoms IDS45 the Positive and Negative Symptoms Scale PANSS46 the Clinician Global Improvement CGI scale47 the Binge Eating Scale BES 48 BMI waist circumference and metabolic variables fasting lipids glucose insulin
Subjects will be inpatients or outpatients at the time of randomization to olanzapine-zonisamide or olanzapine-placebo Throughout the study psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded
Subjects will be inpatients or outpatients at the time of randomization to olanzapine-zonisamide or olanzapine-placebo Throughout the study psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded
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-MC-X269 | None | None | None |