Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers - Full Text View

Sponsor:	University Hospital, Montpellier
Information provided by:	University Hospital, Montpellier
ClinicalTrials.gov Identifier:	NCT00285155

Purpose

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	Intervention
Healthy	Drug: Bupropion

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

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

Estimated Enrollment:	12
Study Start Date:	November 2004
Study Completion Date:	February 2006

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

Ages Eligible for Study:	18 Years to 35 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285155

Locations

France
Centre d'Investigation Clinique
Montpellier, France, 34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Principal Investigator:

Pierre PETIT, MD-PhD

Centre d'Investigation Clinique

More Information

No publications provided

Study ID Numbers:	UF7759
Study First Received:	January 31, 2006
Last Updated:	August 8, 2007
ClinicalTrials.gov Identifier:	NCT00285155 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Montpellier:

bupropion
repeated dose
healthy volunteers
cognitive function

behaviour
tolerance
Persons

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions

Therapeutic Uses
Bupropion
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 22, 2009