Effects of Modafinil on Olanzapine Weight Gain

NCT00636896 | Completed

• 1 other identifier: FID-US-X297
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Keywords

weight gain; olanzapine; atypical antipsychotic

Outcome Measures

Primary Outcomes (1)

• Change in weight

  3 weeks

Secondary Outcomes (8)

• Change in Kilocalories consumed

  Over 3 weeks

• Change in Epworth sleep scale

  3 weeks

• Change in Food Craving Inventory

  3 weeks

• Change in delta ghrelin

  3 weeks

• Change in delta PYY3-36

  3 weeks

Study Arms (2)

1

EXPERIMENTAL

Olanzapine 10 mg plus modafinil 200 mg

Drug: Olanzapine plus modafinil

2

PLACEBO COMPARATOR

Olanzapine plus Placebo

Drug: Olanzapine plus placebo

Interventions

Olanzapine plus modafinil DRUG

Olanzapine 10 mg/d plus modafinil 200 mg/d

Also known as: Zyprexa, Provigil

1

Olanzapine plus placebo DRUG

Olanzapine 10 mg/d plus placebo

Also known as: Zyprexa, Provigil

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Neuropsychiatric Research Institute, Fargo, North Dakota: lead
• Eli Lilly and Company: collaborator
• University of North Dakota: collaborator

Study Sites (1)

Neuropsychiatric Research Institute

Fargo, North Dakota, 58103, United States

Location

Related Publications (2)

• Roerig JL, Steffen KJ, Mitchell JE, Crosby RD, Gosnell BA. A comparison of the effects of olanzapine and risperidone versus placebo on ghrelin plasma levels. J Clin Psychopharmacol. 2008 Feb;28(1):21-6. doi: 10.1097/jcp.0b013e3181613325.

  PMID: 18204336 BACKGROUND

• Roerig JL, Mitchell JE, de Zwaan M, Crosby RD, Gosnell BA, Steffen KJ, Wonderlich SA. A comparison of the effects of olanzapine and risperidone versus placebo on eating behaviors. J Clin Psychopharmacol. 2005 Oct;25(5):413-8. doi: 10.1097/01.jcp.0000177549.36585.29.

  PMID: 16160615 BACKGROUND

Related Links

• Neuropsychiatric Research Institute web page

MeSH Terms

Conditions

Weight Gain

Interventions

Olanzapine; Modafinil

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James L Roerig, PharmD

  University of North Dakota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2008
• First Posted: March 17, 2008
• Study Start: July 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 17, 2008

Record last verified: 2008-03

Locations

US (1)