Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285155
Status:
COMPLETED
Last Update Posted:
2007-08-09
First Post:
2006-01-31
Brief Title:
Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None