Clinical trial NCT00044187: The Assessment of a Weight-Gain Agent for the Treatment of Olanzapine-Associated Anti-Obesity Agent in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, and Bipolar I Disorder
Official title: The Assessment of a Anti-Obesity Agent for the Treatment of Olanzapine-Associated Weight Gain in Patients With Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder and Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Psychotic Disorders
Bipolar Disorder
Keywords: schizoaffective disorder
schizophreniform disorder
bipolar I disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-08-23
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: El Centro
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lafayette
country: United States
state: Indiana
city: Prairie Village
country: United States
state: Kansas
city: Milford
country: United States
state: Massachusetts
city: Clementon
country: United States
state: New Jersey
city: Beachwood
country: United States
state: Ohio
city: Johnson City
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
Study officials:
References: