A Study on the Effect of Methylphenidate on Creativity of Healthy Adults

November 18, 2014 updated by: Shalvata Mental Health Center
Creative cognition plays an important role in art, invention and innovation, as well as in everyday life and thus has a significant effect on society as a whole. Research with healthy, normal participants and those with attention deficit hyperactivity disorder indicates a possible inverse relationship between attentional function and creativity. This evidence raises the possibility that Methylphenidate (MPH; Ritalin) could decrease creativity in people using it for cognitive enhancement. However, this question has not been addressed by previous studies. Hence, the present study aims to examine the effect of MPH on creativity in healthy young adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background:

The past decade has seen a rise in the use of prescription stimulants not only by ADHD-diagnosed individual but also by normal healthy individuals for cognitive enhancement. This resulted in a corresponding escalation of illicit use, particularly in college students (confirmed by numerous survey results). In light of this trend, an important issue concerning the effect of cognitive enhancement on the way people think, or what could be called "cognitive style", was raised. Specifically, there has been concern that stimulants might decrease creativity in people using the drugs for cognitive enhancement(.

Creativity has been defined as the ability to produce responses which are both novel (i.e., original, rare and unexpected) and suitable (i.e., adaptive and useful according to the task constrains; ). Many models have been suggested to explain creativity. According to the well established twofold model of creativity, the creative process begins with an associative generation of crudely formed ideas, which is followed by an expansion and exploration of these ideas through a process of evaluation . Since creativity plays an important role in producing novel and useful ideas , it was further speculated that in case of cognitive enhancers continues to be more widely practiced and indeed impair creativity, the effect on society as a whole could be grave The question of whether stimulants might decrease creativity is yet to be elucidated, given that most of previous studies focused on ADHD-diagnosed children, with mixed results; While some of them found that stimulants maintained creativity, others reported it actually worsened the scores on tasks assessing creativity.

Moreover, despite the increase in both illicit and prescribed stimulant use by healthy adults (discussed above) the study by Farah et al.(2009), is so far the only published report investigating stimulant effects on creativity among these individuals. The authors examined the effect of Adderall (a mixture of amphetamine salts) upon creativity, in 16 healthy adults on four tests of creativity, "two tasks requiring divergent thought and two requiring convergent thought (p. 542)." Only performance on the convergent tasks was affected, and the effect depended on baseline performance: in one case enhancing it, particularly for lower-performing individuals, and in the other case enhancing it for the lower-performing and impairing it for higher-performing individuals. This pattern of differential effect of stimulants based on baseline performance, has been noted in other studies of stimulants and cognition and is not unique to creative thought.

Hence, the question of whether stimulants might decrease creativity in healthy adults using the drugs for cognitive enhancement is still open. To best of our knowledge, though MPH is a widely used by healthy normal individuals to enhance cognition, its effect upon creativity of healthy adults has not been studied before. We therefore sought to investigate the effect of MPH upon creativity in healthy adults.

Participants:

The experiment will include a group of 30 healthy adults (male and female). Participants, aged 21-40 years, will be recruited through an advertisement posted at the University of Haifa (including the website of Haifa University).

Screening Phase:

Potential subjects will be required to arrive at the Social and Affective Neuroscience Lab in Haifa University for two visits:

On the first visit, the risks and requirements of this clinical research trial will be explained to each potential subject. Those volunteering to take part will read and sign the Informed Consent Form for participation in the clinical research trial before any trial-related procedures are performed

  • Upon obtaining the signed informed consent, inclusion and exclusion criteria will be reviewed to verify the subject's eligibility. Therefore all participants will be interviewed by psychiatrist with the Minimal Structured Clinical Interview for DSM-IV Axis I (SCID-I; First, Gibbons, Spitzer, & Williams, 1995) to exclude those with the presence of lifetime diagnoses of any Axis I disorder.
  • In addition, to rule out ADHD, participants will be required to fill in the following questionnaires: conners ADHD Adults Rating-Scale, ASRS v1.1-18 and Wender-Utah self-report rating- scales, Adult ADHD Self-Report Scale (ASRS) Symptom Checklist. Moreover, to rule out any other clinical disorder.
  • Each participant will go through a physical examination by a physician and an ECG test to eliminate the risk of previously undiagnosed arrhythmia.

In one of the visits, participants will receive a capsule containing Methylphenidate or placebo (prior to performing the tasks), and in the other visit they will receive a capsule containing placebo. Randomization will be done by the psychiatrist, so that both experimenter and participants are blind to the content of the capsule (The psychiatrist's contact information will be provided in the Informed Consent Form).

MPH dosage will be determined according to participants' body weight: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participants, aged 21-40 years

Exclusion Criteria:

  1. People diagnosed with a psychiatric clinical disorder and /or taking psychotropic drugs (whether prescription drugs, herbal extracts or illegal drugs), which may impair their performance in tasks that are used in the study).

  2. People for whom there is a contra-indication for consuming Ritalin:

    People who are or were diagnosed with cardiac medical condition, hypertension, liver damage, glaucoma or neurologic disorders (e.g. epilepsy, CVA, parkinson's, Aneurism, brain SOL, MS).

  3. Pregnant or nursing women; female participants will be required to report whether they are pregnant, and in case they are, they will not participate.
  4. Reported use of drugs at the previous 30 days.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Healthy adults
Participants, aged 21-40 years, will be recruited through an advertisement posted at the University of Haifa (including the website of Haifa University).
Drug: MPH
a capsule containing 20 mg
Other Names:
  • methylphenidate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Alternate Uses Task
Time Frame: 30 min
This is a standard measure of divergent thinking, whose stimuli and responses are verbal. Subjects will be presented with a list of six common objects (shoe , can, stapler, tire, drinking glass, cardboard box) and will be asked to list as many alternate uses as possible for each object, within a ten minute time limit (the most common everyday use is indicated in parenthesis). Fluency, flexibility and originality will be scored. Original responses will be defined as statistically infrequent responses according to a pretest conducted in our lab
30 min

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Remote Associates Test (RAT)
Time Frame: 20 min
The task in a RAT problem is, given three words, to find a fourth word that connects them. (For example, lick, mine, shaker: Answer, salt.) RAT problems require problem solvers to search for distantly related information, and have become a benchmark test of creativity).
20 min
The Balloon Analogue Risk Task (BART):
Time Frame: 10 min
A computerized task of risk-taking behavior in both healthy individuals and in neurological and psychiatric populations. Participants will be able to acquire money by inflating a balloon shown on the computer screen by pressing a key on the keyboard, knowing, however, that the balloon can explode at any time, resulting in the loss of the potential gain. Thus, the participant must balance the potential gain of accruing more money against the potential risk of losing all the money accrued for that balloon.
10 min
The Evaluation Task
Time Frame: 10 min
In the evaluation task participants will be presented with responses of other participants who had performed the AUT previously (with six different items). They will be instructed to rate the general levels of appropriateness of each response and then rate the subcomponents of appropriateness namely, uniqueness, usefulness and deviance by using a 5 points rating scales (ranging from 'not at all' to 'highly' appropriate/unique/useful/deviant).
10 min
Torrance Tests for Creative Thinking (TTCT):
Time Frame: 10 min
the circles subset of the figural part of the TTCT will be used. Participants will be presented with a page of circle. They will be instructed to produce as many different drawings as possible within a time limit of 10 min. Participants will be asked to think of drawings they think no one else could think of. Answers will be scored on fluency, flexibility and originality based on Torrance
10 min
Motivation from having an effect
Time Frame: 12 min
three blocks of trials in which participants respond to colored circles rapidly descanting from the top of the screen. They are then probed from their experience with the task and their motivation to perform it.
12 min
visual selection and awareness
Time Frame: 3 min
a 1-trail task in which participants are oriented to either the inner or outer of two concentric colored circles and then are asked to report the color of both task relevant (oriented) and task irrelevant circles
3 min

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Raven Progressive Matrices Test Verbal fluency
Time Frame: 20 min
  1. Verbal fluency: Verbal fluency will be assessed using two items taken from the Controlled Oral Word Association Test (COWAT). In this test the participants are instructed to, during one minute each, generate words beginning with a given letter . All words, except proper nouns and names, are allowed.
  2. Raven Progressive Matrices Test which assesses non-verbal intelligence
20 min

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shalvata Mental Health Center

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHA -0011-12

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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