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

Normal Volunteers Clinical Trial

— MBBCitalopram  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113943
• Other study ID #: C13-03
• Secondary ID: 2013-003496-35
• Status: Completed
• Phase: Phase 2
• First received: April 7, 2014
• Last updated: February 23, 2016
• Start date: April 2014
• Est. completion date: June 2014

Study information

• Verified date: February 2016
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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, …

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Normal Volunteers

Intervention

Drug:
• Citalopram 30mg

Locations

Country	Name	City	State
France	CIC Neurologie GHPS	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Multiple Time Frame: 2h after placebo, 2h after Citalopram 30mg	No