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Geodon in Weight Loss Study for Bipolar Disorders

Information source: Stanford University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder

Intervention: Ziprasidone/Geodon (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Terence Arthur Ketter, Principal Investigator, Affiliation: Stanford University

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.

Clinical Details

Official title: Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

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

Primary outcome: The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.

Secondary outcome: 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.

Detailed 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Stanford University Bipolar Disorders Clinic

Starting date: January 2007
Last updated: December 11, 2012

Page last updated: August 20, 2015

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