Assessment of Bupropion on Cognitive Function and Behaviour in Healthy Volunteers

August 8, 2007 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Centre d'Investigation Clinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • BMI between 20.0 and 25.00
  • no smoker

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: PIERRE PETIT, MD-PhD, Centre d'Investigation Clinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria

January 31, 2006

First Posted (Estimate)

February 1, 2006

Study Record Updates

Last Update Posted (Estimate)

August 9, 2007

Last Update Submitted That Met QC Criteria

August 8, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF7759

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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