Geodon in Weight Loss Study for Bipolar Disorders

Phase 4

Completed

Conditions: Bipolar Disorder

Interventions: Drug: Ziprasidone/Geodon

Registration Number: NCT00472641

Lead Sponsor: Stanford University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ziprasidone/Geodon	Ziprasidone/Geodon	Ziprasidone/Geodon up to 320 mg per day

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.	Baseline, 12 weeks	The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.

Secondary Outcome Measures

Name	Time	Method
Changes From Baseline to Endpoint in Body Mass Index (BMI)	Baseline, 12 weeks	Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).