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Completed

NCT Number: NCT00285155

Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

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.

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre d'Investigation Clinique

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI between 20.0 and 25.00
  • no smoker

Exclusion criteria

-

Treatment and study plan

bupropion

Drug

Primary outcomes

  1. 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 outcomes

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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Important dates

Study start
2004
Study completion
2006
First posted
Feb 1, 2006
Registry last updated
Aug 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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