Effects of Modafinil on Olanzapine Weight Gain

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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 conducted at baseline and endpoint. Assessments of hunger/satiety, kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be drawn at baseline and endpoint prior to breakfast and two hours post.

Study hypothesis: The modafinil/olanzapine group will gain less weight than the olanzapine/placebo group over three weeks of drug intake.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Neuropsychiatric Research Institute, Fargo, North Dakota
• Collaborators: Eli Lilly and Company; University of North Dakota
• Treatments: Armodafinil; Modafinil; Olanzapine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.