AttentionPhase 4NCT01365897
Effectiveness of Modafinil in Improving Cognitive Performance of University Students
A Phase 4 study testing Modafinil in people with Attention and Memory, Short-Term, run by Universidad de Valparaiso at 2 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention, Memory, Short-Term, Executive Function
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 2 sitesChile
- Study dates
- Sep 2010to Jan 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medicine, Psychology, Obstetrics, Nursing and Kinesiology students of the Universidad de Valparaiso.
Who cannot join
- Patients with Mental Disorders.
- Patients with physical diseases.
- Patients using any psychotropic substances.
- History of chronic diseases.
- Pregnant women.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Escuela de Medicina, Universidad de Valparaiso
Valparaíso, Valparaiso
Escuela de Psicología, Universidad de Valparaiso
Valparaíso, Valparaiso
About this study
Official title: 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.
- Conditions
- Attention, Memory, Short-Term, Executive Function
- Being tested
- Modafinil
- Keywords
- Modafinil, Memory, Executive Functions, Memory, Short-Term, Attention, University Students, Stroop Effect, Digit Span, Backwards Digit Span, Biber Cognitive Estimation Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
Also called Modafinilo
Modafinil 200mg
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Control Group Receives: Drug: Modafinil |
| Modafinil 200mg | Experimental | Modafinil 200mg taken orally. Receives: Drug: Modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Correct Answers in Biber Cognitive Estimation Test
Measured: 2 hours after pill ingestion
Average response latency in Stroop Effect test
Measured: 2 hours after pill ingestion
Average Score in Digit Span test
Measured: 2 hours after pill ingestion
Average Score in Backwards Digit Span test
Measured: 2 hours after pill ingestion
Average percentage of correct answers in Stroop Effect test
Measured: 2 hours after pill ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Investigators
- Alejandro Fernández, Psychologist, Principal investigator, Universidad de ValparaisoEva Madrid, PhD, Study director, Universidad de ValparaisoAndrés Painel, BM BCh, Study director, Universidad de ValparaisoJonathan Norambuena, BM BCh, Study director, Universidad de ValparaisoFranco Mascayano, Psychologist, Study director, Universidad de ValparaisoWalter Lips, Psychiatrist, Study director, Universidad de ValparaisoOrtega Alonso, Psychologist, Study director, Universidad de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365897
- Sponsor's protocol ID
- 04/2010
- Status last verified
- Nov 2010
- First submitted
- 31 May 2011
- Last updated
- 3 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Modafinil in Improving Mnesic Performance and Executive Functions of University Students From Careers of High Academic Performance
- ClinicalTrials.gov ID
- NCT01365897
- Acronym / sponsor ID
- 04/2010
- Conditions
- Attention, Memory, Short-Term, Executive Function
- Keywords
- Modafinil, Memory, Executive Functions, Memory, Short-Term, Attention, University Students, Stroop Effect, Digit Span
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: ModafinilControl Group |
| Modafinil 200mg | Experimental | Drug: ModafinilModafinil 200mg taken orally. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Medicine, Psychology, Obstetrics, Nursing and Kinesiology students of the Universidad de Valparaiso.
Key exclusion criteria (5 listed)
- Patients with Mental Disorders.
- Patients with physical diseases.
- Patients using any psychotropic substances.
- History of chronic diseases.
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ModafinilAlso: ModafiniloModafinil 200mg | Drug | Modafinil 200mg, Placebo |
Primary outcome
Average Correct Answers in Biber Cognitive Estimation Test
Time frame: 2 hours after pill ingestion
Average response latency in Stroop Effect test
Time frame: 2 hours after pill ingestion
Average Score in Digit Span test
Time frame: 2 hours after pill ingestion
Average Score in Backwards Digit Span test
Time frame: 2 hours after pill ingestion
Average percentage of correct answers in Stroop Effect test
Time frame: 2 hours after pill ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Fernández, Psychologist principal investigator
Universidad de Valparaiso
Eva Madrid, PhD study director
Universidad de Valparaiso
Andrés Painel, BM BCh study director
Universidad de Valparaiso
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Modafinil in people with Attention and Memory, Short-Term, run by Universidad de Valparaiso at 2 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Correct Answers in Biber Cognitive Estimation Test (time frame: 2 hours after pill ingestion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2011.