Geodon in Weight Loss Study for Bipolar Disorders

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NCT00472641

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Study Location
Stanford University School of Medicine
Stanford, California, 94305, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Geodon in Weight Loss Study for Bipolar Disorders
Official Title  ICMJE Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Drug: Ziprasidone/Geodon
Ziprasidone/Geodon
Study Arms  ICMJE Experimental: Ziprasidone/Geodon
Ziprasidone/Geodon up to 320 mg per day
Intervention: Drug: Ziprasidone/Geodon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2007)		25
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00472641
Other Study ID Numbers  ICMJE 96972
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Terrence Ketter, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Terence Arthur KetterStanford University
PRS Account Stanford University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP