Normal VolunteersPhase 2MBBCitalopramNCT02113943
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Citalopram on Motivation
A Phase 2 study testing Citalopram 30mg in people with Normal Volunteers, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of the current study is to examine the role of serotonin on the cognitive parameters of motivation. They are embedded in a conceptual framework of motivation that merges decision-making and reinforcement learning theories. Every action is conceived as path from one state to another. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Volunteers
- What is being tested?
- Citalopram 30mg
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Jun 2014
- Phase
- Phase 2
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman, age ≥ 18 and < 50
- Weight between 50 kg and 90 kg.
- No contraindication to effort
- No evolutive pathology that could interfere with the current study signed consent
- medical insurance ("sécurité sociale")
Who cannot join
- Age < 18 or > 50
- Smokers
- Person under curatorship, or guardianship, or with civil rights deprivation
- History of neurologic or psychiatric pathology
- Presence of any psychotropic treatment
- Chronic or actual consumption of alcohol, or psychotropic drugs
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- pregnancy, breastfeeding
- Woman of childbearing potential without effective contraception
- Hypersensitivity to atomoxetine or other constituents of the product
- Pheochromocytoma
- Narrow angle Glaucoma
- Liver failure
- Severe Cardiovascular Disorders
- Severe Cerebrovascular Discorders
- Treatment with non-selective Monoamine Oxidase Inhibitor (MAOI) : iproniazide.
- Treatment with Linezoline, Lithium, Milleperthuis, Tramadol, tryptans.
- Treatment with Pimozide, or treatment that can induce a QT prolongation (neuroleptics, class IA and III antiarrythmic, moxifloxacine, erythromicine, methadone, mefloquine, tricyclic antidepressants, lithium, cisapride), or treatment that can induce an hydroelectrolytic inbalance (thiazide diuretics).
- Treatment with Anticoagulants
- Treatment that can decrease seizure threshold: antidepressants, neuroleptics, mefloquine, buproprione, tramadol
- Enzyme inducers, (rifampicine, …)
- Treatment that can interfere with the performance of the subject: beta2 adrenergic agonists, analgesics, corticosteroïds, anti-inflammatory drugs, …
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Comparative Monocentrique, randomisée, en Cross-over, en Double Aveugle, Contre Placebo, de l'Action du Citalopram Sur Les paramètres Cognitifs de la Motivation
The aim of the current study is to examine the role of serotonin on the cognitive parameters of motivation. They are embedded in a conceptual framework of motivation that merges decision-making and reinforcement learning theories. Every action is conceived as path from one state to another. The different states are associated to different values (positive for rewards and negative for punishments), and the different actions to different costs (risk, effort and delay). The tasks are designed such that the sensitivity to the state and action parameters can be inferred by fitting computational models.The primary objective is to characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive force task, in which participants are asked to squeeze a hand grip to win monetary rewards. Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive parameters of motivation (assessed with a motivational battery that includes rating, choice and learning tasks).
- Conditions
- Normal Volunteers
- Being tested
- Citalopram 30mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citalopram 30mgDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reward sensitivity
Apathy will be assessed as the sensitivity to rewards in an incentive force task.
The primary Outcome measure is the change in this parameter between the placebo condition and the Citalopram condition.
Measured: Multiple Time Frame: 2h after placebo, 2h after Citalopram 30mg
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VolunteersStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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 2
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jean Christophe Corvol, MCU-PH, Principal investigator, CIC Neurologie GH Pitié Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113943
- Sponsor's protocol ID
- C13-03
- Other IDs
- 2013-003496-35
- Acronym
- MBBCitalopram
- Status last verified
- Feb 2016
- First submitted
- 7 Apr 2014
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No