Geodon in Weight Loss Study for Bipolar Disorders

Original Study ID : 96972

NCT ID : NCT00472641

Brief Title : Geodon in Weight Loss Study for Bipolar Disorders

Official Title : 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.

Source : Stanford University

Overall Status : Active, not recruiting

Start Date : January 2007

Official Title : N/A

Phase : Interventional

Study Design : Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Enrollment : 25

Verification Date : March 2008

First Received Date : May 11, 2007

Trial 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

Gender : Both

Minimum Age : 18 Years

Maximum Age : 65 Years

Healthy Volunteers : No

Facilities

Facility Name : Stanford University School of Medicine

City : Stanford

State : California

Zip Code : 94305

Country : United States

Clinical Trial Name -Geodon in Weight Loss Study for Bipolar Disorders