Status:
COMPLETED
Effects of Modafinil on Olanzapine Weight Gain
Lead Sponsor:
Neuropsychiatric Research Institute, Fargo, North Dakota
Collaborating Sponsors:
Eli Lilly and Company
University of North Dakota
Conditions:
Weight Gain
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This study is designed as a 3 week, randomized, double blind, placebo controlled, trial. Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab assessments will be condu...
Detailed Description
Atypical antipsychotics have become the drugs of choice in the treatment of schizophrenia as well as acute and maintenance therapy for bipolar disorder. In addition, affective disorders have been foun...
Eligibility Criteria
Inclusion
- Male or female subjects between the ages of 18 and 60 years.
- Women of child bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline.
- Subjects must be of good general health by history and physical exam.
Exclusion
- Subjects who are allergic to olanzapine or modafinil.
- Subjects with a history of a neuroleptic malignant syndrome.
- Subjects who have a body mass index at visit 2 less than 20 kg/m2 or greater than 27 kg/m2.
- Subjects who are restrictive eaters according to the restraint subscale of the Eating Disorder Evaluation (EDE).
- Women who are pregnant or nursing at the time of the study.
- Subjects who are lactose intolerant.
- Subjects with diabetes mellitus.
- Subjects experiencing clinically significant, unstable neurological, cardiac (including cardiac conduction defects), hepatic, renal disease or narrow angle glaucoma.
- Subjects diagnosed with anorexia nervosa, bulimia nervosa, or binge eating disorder.
- Subjects currently or with a past history of meeting DSM-IV diagnostic criteria for schizophrenia, schizoaffective disorder, bipolar disorder or substance abuse.
- Subjects who have participated in an investigational drug study in past 30 days.
- Subjects who are receiving any prescription medications other than oral contraceptives that would interact with the study medication or influence appetite or weight.
- Subjects who smoke or use any nicotine products.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00636896
Start Date
July 1 2006
End Date
August 1 2007
Last Update
March 17 2008
Active Locations (1)
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1
Neuropsychiatric Research Institute
Fargo, North Dakota, United States, 58103