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
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
2 other identifiers
interventional
130
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 schizophrenia
Started Apr 2001
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
August 21, 2002
CompletedFirst Posted
Study publicly available on registry
August 23, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedJuly 19, 2006
July 1, 2006
August 21, 2002
July 18, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
El Centro, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Boise, Idaho, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Lafayette, Indiana, United States
Unknown Facility
Prairie Village, Kansas, United States
Unknown Facility
Milford, Massachusetts, United States
Unknown Facility
Clementon, New Jersey, United States
Unknown Facility
Beachwood, Ohio, United States
Unknown Facility
Johnson City, Tennessee, United States
Unknown Facility
Memphis, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Richmond, Virginia, United States
Unknown Facility
Bellevue, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 21, 2002
First Posted
August 23, 2002
Study Start
April 1, 2001
Study Completion
September 1, 2003
Last Updated
July 19, 2006
Record last verified: 2006-07