Effects of Modafinil on Olanzapine Weight Gain

Completed · Not applicable · Has a placebo group

Conditions studied: Weight Gain

In brief

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.

Key facts

Study ID

NCT00636896

Run by

Neuropsychiatric Research Institute, Fargo, North Dakota

People needed

50

Starts

2006-07-01

Expected to finish

2007-08-01

Last updated by the study team

2008-03-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Neuropsychiatric Research Institute — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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