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Predicting the wide ranging effects of enhancing dopamine on cognition


- candidate number18172
- NTR NumberNTR4653
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jun-2014
- Secondary IDsNL47166.091.13  2013/568; CMO / METC Arnhem Nijmegen
- Public TitlePredicting the wide ranging effects of enhancing dopamine on cognition
- Scientific TitlePredicting the wide ranging effects of enhancing dopamine on cognition
- ACRONYMDopamine & Cognition
- hypothesis
- Healt Condition(s) or Problem(s) studiedDopamine, Cognition, Working Memory
- Inclusion criteria1. Healthy volunteers;
2. Age 18 - 45 years;
3. Normal or corrected-to-normal vision;
4. Normal uncorrected hearing;
5. Willingness and ability to give written informed consent and willingness and ability to understand the nature and content, to participate and to comply with the study requirements.
- Exclusion criteria1. History of / current
psychiatric / neurological treatment
neurological treatment
endocrine treatment
requent autonomic failure (e.g., vasovagal reflex syncope).
clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, ocular or pulmonary disease
epilepsy in adulthood (inclusion when no insult after 18 years of age, no current medication for epilepsy and no insult in the last five years)
drug dependence (opiate, LSD, (meth)amphetamine, cocaine, solvents, or barbiturate) or alcohol dependence
Diabetes
2. Suicidality
3. Medication use:
MAO inhibitor, anaesthetic, anti-depressant or anti psychotic drugs within the week prior to the start of the study.
psychotropic medication, or of recreational drugs over a period of 24 hours prior to each test session, and use of alcohol within the last 24 hours before each measurement.
Regular use of corticosteroids.
4. Uncontrolled hypertension, defined as diastolic blood pressure at rest > 95 mmHg or systolic blood pressure at rest > 180 mmHg
5. Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline travel).
6 .Possible pregnancy or breastfeeding
7. Lactose intolerance (placebo pill is a lactose product)
8. One first degree or two or more second degree family members with a history of sudden death or ventricular arrhythmia
9. First degree family member with schizophrenia or bipolar disorder
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2014
- planned closingdate1-feb-2017
- Target number of participants100
- InterventionsParticipants will twice complete a battery of computerized tests after administration of methylphenidate / placebo. On the day preceding testing, subjects will have to adhere to some simple restrictions with respect to medication, alcohol and drug intake.
- Primary outcomeEffects of methylphenidate on behavioural performance on a battery of computerized tasks:
1. Social Learning (contrast of personal versus social learning)
2. Working memory performance
3-4. Motivational influences on instrumental behaviour (Pavlovian-instrumental transfer and motivational Go/Nogo tasks)
5. Demand selection task task (Biases towards easy/difficult conditions)
6. Probabilistic reversal learning (reinforcement sensitivity and behavioural flexibility)
- Secondary outcomeBaseline personality questionnaires:
Spielberger Trait Anxiety Inventory (Spielberger, 2010);
Multidimensional Scale of Perceived Social Support (Martinez et al., 2010); (http://www.yorku.ca/rokada/psyctest/socsupp.pdf)
Dominance scale (Kalma et al., 1993);
Barratt Simplified Measure of Social Status (Martinez et al., 2010 -http://socialclassoncampus.blogspot.co.uk/2012/06/barratt-simplified-measure-of-social.html);
The Beck Depression Inventory (Beck, Ward, Mendelson, Mock, & Erbaugh, 1961);
Positive and negative affect scale (Watson et al., 1988)
The BIS/BAS (Behavioural Inhibition Scale/Behavioural Activation (BIS/BAS) Scale (Carver & White, 1994);
The Barratt Impulsiveness Scale (Patton, Stanford, & Barratt, 1995);
Need for Cognition Scale (Cacioppo, Pettz, and Kao, 1984)

Baseline assessment of executive function
- Listening span (Daneman and Carpenter, 1980);
- Digit Span (Wechsler 2008);
- Dutch Adult reading test (NLV - Schmand et al., 1991).

Methylphenidate-induced changes in mood and physiological measures
- Positive Affect Negative Affect (PANAS; Watson et al., 1988);
- Mood rating scale (Bond & Lader, 1974);
- Changes in blood pressure and heart rate;
- Medical symptoms visual analogue rating scale.
- Timepoints2 separate testing days for placebo and drug conditions. Total testing time 4-5 hrs, 1 week - 2 months apart, starting time within 90 mins of same time of day.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Roshan Cools
- CONTACT for SCIENTIFIC QUERIES Roshan Cools
- Sponsor/Initiator Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
NWO
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD19-jun-2014 - 11-sep-2014


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