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van CCT (UK)

van CCT (UK)

The role of testosterone in value-based decision making

- candidate number24517
- NTR NumberNTR5908
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2016
- Secondary IDsNL49277.091.14 
- Public TitleThe role of testosterone in value-based decision making
- Scientific TitleThe role of testosterone in value-based decision making - An exploratory investigation into the effects of testosterone on choice behavior and its underlying psychological processes
- hypothesisTwo often-iterated and relatively widespread, but probably too narrow, views of testosterone are that (a) it is first and foremost a "social" hormone, and that (b) higher levels of testosterone are associated with mainly negative consequences. However, more recent evidence suggests that testosterone effects actually extend beyond the purely social domain and are not only negative but depend on the context. However, under which circumstances which effect is to be expected is not known. Furthermore, very little is known about the underlying (psychological) mechanisms by which testosterone affects decisions and behaviors. Therefore, the current study investigates how testosterone influences value-based decision making in a social versus non-social context, using different paradigms that allow decomposition into underlying mechanisms. Based on the literature, we derived two competing hypotheses:
1) Testosterone has effects in a social context only, and will have negative consequences on decision-making (i.e., resulting in less pro-social choices);
(2) Testosterone will have effects in both a social and non-social context, and will result in more optimal, goal-directed choices (i.e., maximizing own benefit).
- Healt Condition(s) or Problem(s) studiedPsychological problems, Decision-making, Testosteron
- Inclusion criteria- Healthy female volunteers between 18 and 35 years of age
- Use of single-phase oral contraception with testing only during the 3-week period they take these contraceptives, and not during menstruation (to control for the possible effect of hormonal changes related to the menstrual cycle)
- Exclusion criteria- Abnormal hearing
- Abnormal and uncorrected vision
- History of prescribed medication within the month prior to the start of the study
- History of ‘over the counter’ medication 2 month prior to the start of the study with exception of occasional use of paracetamol and similar over-the-counter medication (aspirin etc)
- History of drug- dependence: Alcohol, opiate, LSD, (meth)amphetamine, cocaine, solvents, cannabis, or barbiturate
- Average use of more than 3 alcoholic beverages daily (max. 21 beverages weekly)
- Average use of psychotropic medication or recreational drugs weekly or more
- Use of psychotropic medication, or of recreational drugs over a period of 72 hours prior to the test session
- Use of alcohol within the last 24 hours before the measurement
- History of cannabis usage within 2 month prior to the start of the study
- Habitual smoking, i.e. more than a pack of cigarettes per week and a self-reported inability or unease to cease smoking for 24 hours prior to testing
- Regular use of corticosteroids
- (History of) neurological treatment
- (History of) psychiatric treatment
- (History of) endocrine treatment
- (History of) clinically significant hepatic, cardiac , obstructive respiratory, renal , cerebrovascular, metabolic or pulmonary disease
- (History of) epilepsy
- (History of) autonomic failure (e.g., vasovagal reflex syncope)
- Increased risk for glaucoma
- Diabetes
- Current parodontitis
- Family history of schizophrenia, bipolar disorder or major depressive disorder
- Intense daily physical exercise
- Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timeline travel
- Pregnancy
- Breast-feeding
- Body Mass Index < 18.5 or > 25
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-dec-2015
- planned closingdate23-jun-2016
- Target number of participants80
- InterventionsParticipants will receive either 0.5 mg testosterone or a placebo dose by sublingual administration and will perform several computerized tasks and complete several self-report questionnaires. The total duration of the experiment will be 6 hours and 30 minutes, including a 3.5 hours waiting period between drug administration and behavioral testing and 2 hours of experimental tasks. Furthermore, participants will provide 5 saliva samples in total to measure testosterone and cortisol levels.
- Primary outcome- Behavioral performance on computerized tasks assessing choice behavior and their underlying psychological mechanisms in contexts including risky choice, intertemporal choice, and reward-history and social learning in reinforcement-based decision making
- Secondary outcome- Salivary cortisol and testosterone hormone levels
- Subjective measurements on self-report questionnaires
- TimepointsThe intervention was completed in a single session of 6 hours and 30 minutes.
- Trial web site
- statusinclusion stopped: follow-up
- Sponsor/Initiator Behavioural Science Institute, Radboud University Nijmegen, Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryRationale:
Testosterone plays a major role in motivated behavior. However, it remains unknown how testosterone affects the psychological mechanisms underlying value-based decision making and choice behavior. In the current study we will investigate the psychological mechanisms by which testosterone influences important types of decisions, such as risky and intertemporal choices, and learning based on reward history versus social input. We conduct a placebo-controlled double-blind testosterone administration study to causally investigate testosterone's role in these types of decisions.

Study objective:
To identify the psychological mechanisms via which testosterone modulates value-based decision making (we use the term value-based decisions as it covers all the types of decisions we investigate in the study, i.e., decisions in both social and non-social contexts).

Study design:
Participants will be tested in a randomized, double-blind, placebo controlled, between-group design.

Study population:
Participants will be healthy female volunteers between 18 and 35 years of age.

One group of participants will receive a single dose of 0.5 mg testosterone. Another group will receive a similar dose of a matched placebo.

Main study parameters/endpoints:
1. Behavioral performance on computerized tasks assessing choice behavior and their underlying psychological mechanisms
2. Testosterone and cortisol hormone levels measured in saliva
3. Subjective measurements on self-report questionnaires
- Main changes (audit trail)
- RECORD21-jun-2016 - 8-jul-2016

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