Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00285155

Recruitment Status : Completed

First Posted : February 1, 2006

Last Update Posted : August 9, 2007

Sponsor:

Information provided by:

University Hospital, Montpellier

Study Description

Brief Summary:

To evaluate the effects of a 14-day repeated dose of 150 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, after sleep deprivation in 12 healthy male subjects.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Bupropion	Not Applicable

Detailed Description:

The aim of this controlled double-blind randomized 3-session cross-over designed study is to evaluate the effects of a single dose of 150 mg and a 14-day repeated dose of 300 mg bupropion (therapeutic dose) on cognitive and executive functions, behaviour and subjective feelings, and some physical parameters after sleep deprivation in 12 trained healthy volunteers (18-35 years old).

Cognitive and executive functions were assessed by reaction times, critical flicker fusion test, Stroop test, digit symbol substitution test, span test and short term recal of pictures, tapping and tracking tests.

Behaviour and subjective effects explored were :

feelings frequently experienced with psychotropic drugs assessed by ARCI,
some mood states as tension, depression, anger, vigor, fatigue and confusion assessed by both POMS and Norris visual analogic scales,
sleep assessed by LSEQ,
feeding behaviour assessed by food intake during a meal test and self-ratings of appetite and satiety,

Physical parameters were :

rest and orthostatic blood pressure and heart rate,
body temperature and weight.

Bupropion was tested versus both placebo and 20 mg methylphenidate as positive control. Each subject received the 3 treatments, sequently randomized, with a 17-day wash-out period between sessions. Each session was organized as follow :

2 20-hour hospitalisations consisting in adverse effects review, physical examination, test training, sleep deprivation, drug compliance evaluation, drug dosing and dispensation, and assessments described above,
2 visits consisting in adverse effects review, drug compliance evaluation and drug dispensation.

The total duration of participation for the subjects was 106 days.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Study Start Date :	November 2004
Actual Study Completion Date :	February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Cognitive and executive functions after the first dose and the 14-day treatment.Subjective feelings after the first dose and the 14-day treatment : ARCI, Norris and POMS scales.

Secondary Outcome Measures :

Sleep questionnaire after the 14-day treatment. Energy intake after the 14-day treatment. Blood pressure after one dose and the 14-day treatment

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 35 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

BMI between 20.0 and 25.00
no smoker

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00285155

Locations

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France
Centre d'Investigation Clinique
Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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Principal Investigator:	Pierre PETIT, MD-PhD	Centre d'Investigation Clinique

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chevassus H, Farret A, Gagnol JP, Ponçon CA, Costa F, Roux C, Galtier F, Petit P. Psychological and physiological effects of bupropion compared to methylphenidate after prolonged administration in healthy volunteers (NCT00285155). Eur J Clin Pharmacol. 2013 Apr;69(4):779-87. doi: 10.1007/s00228-012-1418-z. Epub 2012 Oct 9.

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ClinicalTrials.gov Identifier:	NCT00285155
Other Study ID Numbers:	UF7759
First Posted:	February 1, 2006 Key Record Dates
Last Update Posted:	August 9, 2007
Last Verified:	August 2007

Keywords provided by University Hospital, Montpellier:


bupropion repeated dose healthy volunteers cognitive function	behaviour tolerance Persons

Additional relevant MeSH terms:

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Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators	Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors

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