Effectiveness of Modafinil in Improving Cognitive Performance of University Students

June 2, 2011 updated by: Universidad de Valparaiso

Effectiveness of Modafinil in Improving Mnesic Performance and Executive Functions of University Students From Careers of High Academic Performance

The purpose of this study is to determine whether modafinil is effective in the improvement of mnesic performance and executive functions of university students from high academic performance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 4

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

  • Chile
    • V Region
      • Valparaiso, V Region, Chile
        • Escuela de Medicina, Universidad de Valparaíso
      • Valparaiso, V Region, Chile
        • Escuela de Psicología, Universidad de Valparaiso

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 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medicine, Psychology, Obstetrics, Nursing and Kinesiology students of the Universidad de Valparaiso.

Exclusion Criteria:

  • Patients with Mental Disorders.
  • Patients with physical diseases.
  • Patients using any psychotropic substances.
  • History of chronic diseases.
  • Pregnant women.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Control Group
Drug: Modafinil
Modafinil 200mg
Other Names:
  • Modafinilo
Experimental: Modafinil 200mg
Modafinil 200mg taken orally.
Drug: Modafinil
Modafinil 200mg
Other Names:
  • Modafinilo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average Correct Answers in Biber Cognitive Estimation Test
Time Frame: 2 hours after pill ingestion
2 hours after pill ingestion
Average response latency in Stroop Effect test
Time Frame: 2 hours after pill ingestion
2 hours after pill ingestion
Average Score in Digit Span test
Time Frame: 2 hours after pill ingestion
2 hours after pill ingestion
Average Score in Backwards Digit Span test
Time Frame: 2 hours after pill ingestion
2 hours after pill ingestion
Average percentage of correct answers in Stroop Effect test
Time Frame: 2 hours after pill ingestion
2 hours after pill ingestion

Collaborators and Investigators

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

Sponsor

Universidad de Valparaiso

Investigators

  • Principal Investigator: Alejandro Fernández, Psychologist, Universidad de Valparaiso
  • Study Director: Eva Madrid, PhD, Universidad de Valparaiso
  • Study Director: Andrés Painel, BM BCh, Universidad de Valparaiso
  • Study Director: Jonathan Norambuena, BM BCh, Universidad de Valparaiso
  • Study Director: Franco Mascayano, Psychologist, Universidad de Valparaiso
  • Study Director: Walter Lips, Psychiatrist, Universidad de Valparaiso
  • Study Director: Ortega Alonso, Psychologist, Universidad de Valparaiso

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

September 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 31, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2011

Last Update Submitted That Met QC Criteria

June 2, 2011

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04/2010

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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