MBBCitalopram: Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Citalopram on Motivation

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France (Other)

Overall Status

Completed

CT.gov ID

NCT02113943

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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).

Condition or Disease	Intervention/Treatment	Phase
Normal Volunteers	Drug: Citalopram 30mg	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

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

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Outcome Measures

Primary Outcome Measures

Reward sensitivity [Multiple Time Frame: 2h after placebo, 2h after Citalopram 30mg]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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")

Exclusion Criteria:

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
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, …

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIC Neurologie GHPS	Paris		France	75013

Sponsors and Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

Principal Investigator: Jean Christophe Corvol, MCU-PH, CIC Neurologie GH Pitié Salpêtrière

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut National de la Santé Et de la Recherche Médicale, France

ClinicalTrials.gov Identifier:

NCT02113943

Other Study ID Numbers:

C13-03
2013-003496-35

First Posted:

Apr 15, 2014

Last Update Posted:

Feb 24, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Citalopram

Study Results

No Results Posted as of Feb 24, 2016