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

NCT02113943 | Completed Phase 2

• 2 other identifiers: C13-032013-003496-35
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Normal Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Citalopram 30mg DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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")

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

CIC Neurologie GHPS

Paris, 75013, France

Location

MeSH Terms

Interventions

Citalopram

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean Christophe Corvol, MCU-PH

  CIC Neurologie GH Pitié Salpêtrière

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 15, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

FR (1)