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Effectiveness of Modafinil in Improving Cognitive Performance of University Students

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ClinicalTrials.gov Identifier: NCT01365897
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : June 3, 2011
Sponsor:
Information provided by:
Universidad de Valparaiso

Brief Summary:
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 or disease Intervention/treatment Phase
Attention Memory, Short-Term Executive Function Drug: Modafinil Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: College Health

Arm Intervention/treatment
Placebo Comparator: Placebo
Control Group
Drug: Modafinil
Modafinil 200mg
Other Name: Modafinilo

Experimental: Modafinil 200mg
Modafinil 200mg taken orally.
Drug: Modafinil
Modafinil 200mg
Other Name: Modafinilo




Primary Outcome Measures :
  1. Average Correct Answers in Biber Cognitive Estimation Test [ Time Frame: 2 hours after pill ingestion ]
  2. Average response latency in Stroop Effect test [ Time Frame: 2 hours after pill ingestion ]
  3. Average Score in Digit Span test [ Time Frame: 2 hours after pill ingestion ]
  4. Average Score in Backwards Digit Span test [ Time Frame: 2 hours after pill ingestion ]
  5. Average percentage of correct answers in Stroop Effect test [ Time Frame: 2 hours after pill ingestion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365897


Locations
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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
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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

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Responsible Party: Alejandro Fernández, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT01365897     History of Changes
Other Study ID Numbers: 04/2010
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: June 3, 2011
Last Verified: November 2010
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:
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Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action