NCT02378818

Brief Summary

This research focuses on disorders of motivation, responsible for a disability that patients experience daily. It is a disorder that affects behavior, especially social. Mechanisms, which result in these disorders, are poorly understood. This ignorance is responsible for the lack of effective therapy. The investigators realize this work in order to better understand the motivational deficits. The objective of the study is to characterize the cognitive mechanisms of motivational deficits in schizophrenia and depression. To answer the question posed in the research, it is planned to include 35 people with schizophrenia, 35 people with depression and 70 heathy volunteers in the Hospital of Sainte-Anne .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

August 13, 2014

Last Update Submit

January 23, 2018

Conditions

Keywords

SchizophreniaNegative symptomsLack of motivationCognitive characterizationComputational psychiatryDepression

Outcome Measures

Primary Outcomes (2)

  • level of force produced based in incentive reward

    the first inclusion day

  • level of force produced based in incentive reward

    up to third day

Secondary Outcomes (3)

  • consistent level of choice questionnaire

    the first inclusion day

  • The proportion of choosing the expensive option (great effort/big time/immediate effort)

    the first inclusion day

  • The proportion of corrects choice

    the first inclusion day

Study Arms (4)

Schizophrenia patients

OTHER

35 patients, Age between 18 and 65 years, with a diagnosis of schizophrenia and unchanged psychotropic treatment for at least three months before inclusion.

Behavioral: Force task, preference task, discount task, learning task.

Healthy volunteers (schizophrenia)

OTHER

35 healthy volunteers

Behavioral: Force task, preference task, discount task, learning task.

Depressive patients

OTHER
Behavioral: Force task, preference task, discount task, learning task.

Healthy volunteers (depression)

OTHER
Behavioral: Force task, preference task, discount task, learning task.

Interventions

Force task, preference task, discount task, learning task.

Depressive patientsHealthy volunteers (depression)Healthy volunteers (schizophrenia)Schizophrenia patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients :
  • Age between 18 and 65 years
  • Affiliation to a healthy insurance
  • Subjects who were informed and willing to sign the form of free and informed consent and information of the curator if necessary (or consent of the tutor)
  • French native tongue
  • Diagnosis of schizophrenia according to ICD-10, made by a psychiatrist. The subjects are stabilized (less than three items include a score\> = 4 or to the positive level (P) of the PANSS)
  • Healthy volunteers:
  • Age between 18 and 65 years
  • Affiliation to a healthy insurance
  • Subjects who were informed and willing to sign the form of free and informed consent and information curator appropriate
  • French native tongue

You may not qualify if:

  • Patients:
  • Unable major, persons deprived of liberty, pregnant women
  • Enforced hospitalisation
  • Recent abuse (1 week) or chronic use of addictive substances, except tobacco
  • Treatment electro-convulsivo-therapy in the last 6 months
  • Degenerative Pathology, neurological disorder
  • Co-occurrence of a major depressive episode in a schizophrenic patient evaluated by a score\> 10 CDS
  • Difficulty in understanding and expression in French language
  • Deficit of visual acuity or uncorrected hearing
  • Healthy volunteers:
  • Unable major, persons deprived of liberty, pregnant women
  • Current psychiatric disease
  • Psychotropic treatment
  • Recent abuse (1 week) or chronic use of addictive substances, except tobacco
  • Difficulty in understanding and expression in French language
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Sainte Anne

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

SchizophreniaDepression

Interventions

Advisory Committees

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Policy MakingSocial Control, FormalHealth Care Economics and Organizations

Study Officials

  • Raphaël GAILLARD, MD, PhD

    Centre Hospitalier St Anne

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2014

First Posted

March 4, 2015

Study Start

November 21, 2014

Primary Completion

November 1, 2018

Study Completion

January 1, 2019

Last Updated

January 25, 2018

Record last verified: 2017-10

Locations