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Geodon in Weight Loss Study for Bipolar Disorders

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ziprasidone/Geodon
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ziprasidone/Geodon

Arm Description

Ziprasidone/Geodon up to 320 mg per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
May 11, 2007
Last Updated
March 29, 2017
Sponsor
Stanford University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00472641
Brief Title
Geodon in Weight Loss Study for Bipolar Disorders
Official Title
Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ziprasidone/Geodon
Arm Type
Experimental
Arm Description
Ziprasidone/Geodon up to 320 mg per day
Intervention Type
Drug
Intervention Name(s)
Ziprasidone/Geodon
Intervention Description
Ziprasidone/Geodon
Primary Outcome Measure Information:
Title
The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.
Description
The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Changes From Baseline to Endpoint in Body Mass Index (BMI)
Description
Secondary outcome measures will include the change from baseline to endpoint in Body Mass Index (BMI).
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terence Arthur Ketter
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.bipolar.org
Description
Stanford University Bipolar Disorders Clinic

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Geodon in Weight Loss Study for Bipolar Disorders

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