Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
NCT ID: NCT00285155
Last Updated: 2007-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2004-11-30
2006-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
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Bupropion
Eligibility Criteria
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Inclusion Criteria
* no smoker
Exclusion Criteria
18 Years
35 Years
MALE
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Principal Investigators
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Pierre PETIT, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation Clinique
Locations
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Centre d'Investigation Clinique
Montpellier, , France
Countries
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References
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Chevassus H, Farret A, Gagnol JP, Poncon 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.
Other Identifiers
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UF7759
Identifier Type: -
Identifier Source: org_study_id