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Effects of Modafinil on Olanzapine Weight Gain

NCT00636896 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2008-03-17

No results posted yet for this study

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.

Conditions

  • Weight Gain

Interventions

DRUG

Olanzapine plus modafinil

Olanzapine 10 mg/d plus modafinil 200 mg/d

DRUG

Olanzapine plus placebo

Olanzapine 10 mg/d plus placebo

Sponsors & Collaborators

  • Eli Lilly and Company

    collaborator INDUSTRY

  • University of North Dakota

    collaborator OTHER

  • Neuropsychiatric Research Institute, Fargo, North Dakota

    lead OTHER

Principal Investigators

  • James L Roerig, PharmD · University of North Dakota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00636896 on ClinicalTrials.gov