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Effectiveness of Modafinil in Improving Cognitive Performance of University Students

This study has been completed.
Sponsor:
Information provided by:
Universidad de Valparaiso
ClinicalTrials.gov Identifier:
NCT01365897
First received: May 31, 2011
Last updated: June 2, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Attention
Memory, Short-Term
Executive Function
 Drug: Modafinil
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Modafinil in Improving Mnesic Performance and Executive Functions of University Students From Careers of High Academic Performance

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by Universidad de Valparaiso:

Primary Outcome Measures:
  • Average Correct Answers in Biber Cognitive Estimation Test [ Time Frame: 2 hours after pill ingestion ] [ Designated as safety issue: No ]
  • Average response latency in Stroop Effect test [ Time Frame: 2 hours after pill ingestion ] [ Designated as safety issue: No ]
  • Average Score in Digit Span test [ Time Frame: 2 hours after pill ingestion ] [ Designated as safety issue: No ]
  • Average Score in Backwards Digit Span test [ Time Frame: 2 hours after pill ingestion ] [ Designated as safety issue: No ]
  • Average percentage of correct answers in Stroop Effect test [ Time Frame: 2 hours after pill ingestion ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: September 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Control Group
 Drug: Modafinil
Modafinil 200mg
Other Names:
  • Modafinil
  • Modafinilo
Experimental: Modafinil 200mg
Modafinil 200mg taken orally.
 Drug: Modafinil
Modafinil 200mg
Other Names:
  • Modafinil
  • Modafinilo

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365897

Locations
Chile
Escuela de Medicina, Universidad de Valparaiso
Valparaiso, V Region, Chile
Escuela de Psicología, Universidad de Valparaiso
Valparaiso, V Region, Chile
Sponsors and Collaborators
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 Valparaíso
  More Information

No publications provided

Responsible Party: Alejandro Fernández, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT01365897     History of Changes
Other Study ID Numbers: 04/2010
Study First Received: May 31, 2011
Last Updated: June 2, 2011
Health Authority: Chile: Institutional Review Board

Keywords provided by Universidad de Valparaiso:
Modafinil
Memory
Executive Functions
Memory, Short-Term
Attention
 University Students
Stroop Effect
Digit Span
Backwards Digit Span
Biber Cognitive Estimation Test

Additional relevant MeSH terms:
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013