NCT00285155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
Last Updated

August 9, 2007

Status Verified

August 1, 2007

First QC Date

January 31, 2006

Last Update Submit

August 8, 2007

Conditions

Healthy

Keywords

bupropionrepeated dosehealthy volunteerscognitive functionbehaviourtolerancePersons

Outcome Measures

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

Interventions

BupropionDRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 20.0 and 25.00
  • no smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique

Montpellier, 34295, France

Location

Related Publications (1)

  • Chevassus H, Farret A, Gagnol JP, Poncon CA, Costa F, Roux C, Galtier F, Petit P. Psychological and physiological effects of bupropion compared to methylphenidate after prolonged administration in healthy volunteers (NCT00285155). Eur J Clin Pharmacol. 2013 Apr;69(4):779-87. doi: 10.1007/s00228-012-1418-z. Epub 2012 Oct 9.

    PMID: 23052417DERIVED

MeSH Terms

Conditions

Behavior

Interventions

Bupropion

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Pierre PETIT, MD-PhD

    Centre d'Investigation Clinique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2006

First Posted

February 1, 2006

Study Start

November 1, 2004

Study Completion

February 1, 2006

Last Updated

August 9, 2007

Record last verified: 2007-08

Locations

FR(1)