Geodon in Weight Loss Study for Bipolar Disorders

Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

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 Overview

• Status: Completed
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Ziprasidone/Geodon

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ziprasidone/Geodon; Ziprasidone/Geodon up to 320 mg per day	Drug: Ziprasidone/Geodon; Ziprasidone/Geodon

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Pfizer
• Investigators: Principal Investigator: Terence Arthur Ketter, Stanford University

Publications and helpful links

Helpful Links

• Stanford University Bipolar Disorders Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: May 11, 2007
• First Submitted That Met QC Criteria: May 11, 2007
• First Posted (Estimate): May 14, 2007

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Ziprasidone
• Other Study ID Numbers: 96972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No