Geodon in Weight Loss Study for Bipolar Disorders
This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder|
- The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]change in weight from baseline to endpoint
- Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI) using a random regression mixed effects model, and the rate of change of weight and BMI. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]change from baseline to endpoint in Body Mass Index (BMI) using a random regression mixed effects model, and the rate of change of weight and BMI.
|Study Start Date:||January 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Ziprasidone/Geodon up to 320 mg per day
Other Name: Ziprasidone/Geodon
22 obese and three overweight BD patients (20 female; 10 BD-I, 14 BD-II, 1 BD-NOS) with mean ` SD baseline body mass index (BMI) of 31.8 ` 2.5 kg/m2 received ZIP (mean final dose 190 ` 92 mg/day) for mean of 79.2 ` 23.2 days. Weight was assessed at six weekly and three biweekly visits. Subjects entered the study in diverse mood states. At baseline, 21 were taking second-generation antipsychotics, 7 lithium, and 1 valproate, which could be reduced/discontinued at investigators' discretion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00472641
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Terence Arthur Ketter||Stanford University|