NCT01365897

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

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

September 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
Last Updated

June 3, 2011

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

May 31, 2011

Last Update Submit

June 2, 2011

Conditions

AttentionMemory, Short-TermExecutive Function

Keywords

ModafinilMemoryExecutive FunctionsMemory, Short-TermAttentionUniversity StudentsStroop EffectDigit SpanBackwards Digit SpanBiber Cognitive Estimation Test

Outcome Measures

Primary Outcomes (5)

  • Average Correct Answers in Biber Cognitive Estimation Test

    2 hours after pill ingestion

  • Average response latency in Stroop Effect test

    2 hours after pill ingestion

  • Average Score in Digit Span test

    2 hours after pill ingestion

  • Average Score in Backwards Digit Span test

    2 hours after pill ingestion

  • Average percentage of correct answers in Stroop Effect test

    2 hours after pill ingestion

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Control Group

Drug: Modafinil

Modafinil 200mg

EXPERIMENTAL

Modafinil 200mg taken orally.

Drug: Modafinil

Interventions

ModafinilDRUG

Modafinil 200mg

Also known as: Modafinilo
Modafinil 200mgPlacebo

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Escuela de Medicina, Universidad de Valparaiso

Valparaíso, Región de Valparaíso, Chile

Location

Escuela de Psicología, Universidad de Valparaiso

Valparaíso, Región de Valparaíso, Chile

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Alejandro Fernández, Psychologist

    Universidad de Valparaiso

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 3, 2011

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

June 3, 2011

Record last verified: 2010-11

Locations

CL(2)