Geodon in Weight Loss Study for Bipolar Disorders

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Terrence Ketter, Stanford University
ClinicalTrials.gov Identifier:
NCT00472641
First received: May 11, 2007
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Ziprasidone/Geodon
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    change in weight from baseline to endpoint


Secondary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ziprasidone/Geodon
Ziprasidone/Geodon up to 320 mg per day
Drug: Ziprasidone/Geodon
Ziprasidone/Geodon
Other Name: Ziprasidone/Geodon

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472641

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Pfizer
Investigators
Principal Investigator: Terence Arthur Ketter Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Terrence Ketter, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00472641     History of Changes
Other Study ID Numbers: 96972
Study First Received: May 11, 2007
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 24, 2014