Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Information source: University Hospital, Montpellier
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Bupropion (Drug)
Phase: N/A
Status: Completed
Sponsored by: University Hospital, Montpellier Official(s) and/or principal investigator(s):
Pierre PETIT, MD-PhD, Principal Investigator, Affiliation: Centre d'Investigation Clinique
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.
Clinical Details
Official title: Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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: Sleep questionnaire after the 14-day treatment. Energy intake after the 14-day treatment. Blood pressure after one dose and the 14-day treatment
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- BMI between 20. 0 and 25. 00
- no smoker
Exclusion Criteria:
-
Locations and Contacts
Centre d'Investigation Clinique, Montpellier 34295, France
Additional Information
Starting date: November 2004
Ending date: February 2006
Last updated: August 8, 2007
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