Geodon in Weight Loss Study for Bipolar Disorders

NCT00472641 | Completed Phase 4 Results

• 1 other identifier: 96972
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes From Baseline to Endpoint in Body Mass Index (BMI)

  Baseline, 12 weeks

Study Arms (1)

Ziprasidone/Geodon

EXPERIMENTAL

Ziprasidone/Geodon up to 320 mg per day

Drug: Ziprasidone/Geodon

Interventions

Ziprasidone/Geodon DRUG

Ziprasidone/Geodon

Ziprasidone/Geodon

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Pfizer: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

• Stanford University Bipolar Disorders Clinic

MeSH Terms

Conditions

Bipolar Disorder

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Limitations and Caveats

The current study has noteworthy limitations, including a small sample size, short trial duration, and an open, uncontrolled design.

Results Point of Contact

• Title: Dr. Po W. Wang
• Organization: Stanford University School of Medicine

wangp0@stanford.edu

650-723-2483

Study Officials

• Terence Arthur Ketter

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2007
• First Posted: May 14, 2007
• Study Start: January 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 9, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)