Geodon in Weight Loss Study for Bipolar Disorders

Bipolar Disorder Clinical Trial

Official title:

Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472641
• Other study ID #: 96972
• Status: Completed
• Phase: Phase 4
• First received: May 11, 2007
• Last updated: December 11, 2012
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:Patients will meet the following criteria to be eligible to participate in the study:

• Diagnosis of Bipolar Disorder Type I, Type II, or NOS treated in ongoing therapy with atypical antipsychotic(s) and/or mood stabilizer(s) that have been implicated in causing weight gain (i.e. lithium, valproate, olanzapine, risperidone, quetiapine, aripiprazole).

• Age 18-65 years old

• Males; or nonpregnant, nonlactating females who are postmenopausal, surgically sterilized, or using a barrier method of contraception and have a negative pregnancy test

• Initial body mass index e 30 kg/m2, or e 27 kg/m2 and demonstrating or receiving treatment for metabolic consequences of overweight (fasting total cholesterol e 200mg/dL, fasting triglycerides e 250 mg/dL, or fasting blood glucose e 100 mg/dL).

• Stable medication regimen of at least one month

• Not have been hospitalized due to medical or psychiatric reasons during the past year from date of consent.

• Ability to understand and cooperate with study procedures

• Have signed a written informed consent prior to entering the study Exclusion Criteria:Patients may not participate in the study if they have any of the following conditions:

• One of the following DSM-IV Axis I diagnoses: delirium, dementia, amnestic and other cognitive disorders, schizophrenia, anorexia nervosa or bulimia, or substance abuse or dependence (active within the last month), abuse of illicit drugs (excluding marijuana) within the past month

• Antisocial personality disorder

• Medical complications of obesity such as diabetes, hypertension, hyperlipidemia, and cardiovascular disease unless followed by their own general medical practitioner who authorizes their participation in the trial, and continues to follow them medically and make necessary adjustments of concurrent antidiabetic, antihypertensive, antihyperlipidemic agents during the trial;

• Item 10 (Suicidal Thoughts) on the MADRS greater than or equal to 4

• Suicide attempt within the past three months

• Obesity of endocrine origin

• Seizure disorders

• Progressive neurologic or systemic disorders; HIV

• Other serious illnesses such as cardiac, hepatic (including cirrhosis), renal, respiratory, neurologic, or hematologic disease or glaucoma

• Hypothyroidism or hyperthyroidism unless adequately treated with TSH no more than 10% above or below the limits of the normal range.

• Administration of any investigational drug within 30 days prior to screening

• Allergy or hypersensitivity to ziprasidone

• Administration of clozapine in the prior three months

• Pregnancy within the past six months

• Patients will be discontinued from the study should they develop any significant adverse side effects that cannot be managed by dosage adjustment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Ziprasidone/Geodon
Ziprasidone/Geodon

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.	change in weight from baseline to endpoint	12 weeks	No
Secondary	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.	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.	12 weeks	No

External Links

•   Stanford University Bipolar Disorders Clinic