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

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).

Study Overview

• Status: Completed
• Conditions: Normal Volunteers
• Intervention / Treatment: Drug: Citalopram 30mg

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • CIC Neurologie GHPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Interventional Model: Crossover Assignment
• Masking: Triple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: C13-03; 2013-003496-35 (EudraCT Number)