Olanzapine is currently marketed for the treatment of schizophrenia and acute manic episodes with bipolar 1 disorder. This Anti-obesity Agent is currently marketed for the management of obesity. In this study, the Anti-obesity Agent is being tested to see if it can treat weight gain that may be associated with taking olanzapine.

The purposes of this study are to determine the safety of olanzapine when given in combination with the Anti-obesity Agent and any side effects that might be associated with it and whether weight-gain agent can help treat weight gain that may be associated with taking olanzapine.

Condition	Treatment or Intervention	Phase
Schizophrenia Psychotic Disorders Bipolar Disorder	Drug: Sibutramine	Phase IV

Further Study Details: 

Expected Total Enrollment:  130

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Eligibility Criteria:

• You must be between the ages of 18 and 65. If you have reached your 66th birthday, you will not be able to participate.
• You must have been diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar I disorder and be taking olanzapine.
• You must be able to visit the doctor's office as scheduled for the next 4 months.

Exclusion Criteria:

• You have a history of an illness that would cause weight loss or gain in the near future.
• You have taken remoxipride within the past 6 months.
• You are allergic to olanzapine or Anti-obesity Agent.
• You have uncontrolled high blood pressure, congestive heart failure, or have had a stroke.
• You have a serious medical illness, such as heart, liver, or kidney disease.
• You are pregnant or breast feeding.

California
      El Centro,  California,  United States
Florida
      Jacksonville,  Florida,  United States
      Miami,  Florida,  United States
Idaho
      Boise,  Idaho,  United States
Illinois
      Chicago,  Illinois,  United States
Indiana
      Lafayette,  Indiana,  United States
      Indianapolis,  Indiana,  United States
Kansas
      Prairie Village,  Kansas,  United States
Massachusetts
      Milford,  Massachusetts,  United States
New Jersey
      Clementon,  New Jersey,  United States
Ohio
      Beachwood,  Ohio,  United States
Tennessee
      Memphis,  Tennessee,  United States
      Johnson City,  Tennessee,  United States
Texas
      Houston,  Texas,  United States
Virginia
      Richmond,  Virginia,  United States
Washington
      Bellevue,  Washington,  United States

Study ID Numbers:  5102
Record last reviewed:  September 2002
Last Updated:  October 13, 2004
Record first received:  August 21, 2002
ClinicalTrials.gov Identifier:  NCT00044187
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08