NCT02388607

Brief Summary

Schizophrenia is a psychiatric pathology, which concerns around 1% of adult population. It is characterized by clinical symptoms combining positive and negative symptoms and thinking disorganization. Schizophrenia is also characterized by cognitive deficits, likely to play an important part in adaptation of these patients in their every-day life, and to affect their clinical symptomatology. Among them, there are deficits in sustained attention which are associated with a difficulty for these patients to maintain efficiently their cognitive activity on a source of stimulation or task. This basic attentional process is fundamental for the efficiency of the overall of cognitive processes, and so for all behaviors directed on an aim. The question of whether or not patients with schizophrenia have difficulty sustaining attention is of high relevance, in the sense that it could undermine performance on nearly any task and so provide a compelling causal explanation of many other impairments observed in these patients. Yet it has not been conclusively answered in over four decades of research. Consequently, the main objective of the protocol is to evaluate sustained attention abilities in schizophrenic patients and to better understand the specific functioning of cognitive and neural mechanisms underlying these abilities (attentional resources and cognitive control mechanisms).

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
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2015

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

8 years

First QC Date

December 10, 2014

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assess sustained attention span of patients with schizophrenia

    Subjects are involved in 4 different attentional tasks during which behavioral and electrophysiological measures are recorded in order to evaluate sustained attention abilities and the specific functioning of cognitive and neural mechanisms underlying these abilities in schizophrenic patients.

    two half-days

Secondary Outcomes (1)

  • Study the specific mechanisms underlying attention skills supported in schizophrenic patients

    two half-days

Study Arms (1)

assessing attention span

* Electrophysiological measurements (evocated potentials and spectral densities) * Clinical scales and subjective assessments of difficulty of the tasks performed, and commitment to the task

Other: measurements

Interventions

performance measurements

assessing attention span

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

40 schizophrenic patients versus 40 healthy subjects matched

You may qualify if:

  • age between 18 and 60 years (include)
  • men or women volunteers, hospitalized or not
  • subject affiliated to an health insurance
  • subject having signed an informed consent (for patients):
  • presence of DSM-IV TR criteria for schizophrenia (American Psychiatric Association, 1994)

You may not qualify if:

  • a major somatic disorder or non stabilized
  • medical history likely to affect cerebral anatomy or to be linked to an abnormality (neonatal distress, neurochirurgical intervention, neurological disorders, stroke attack)
  • any disorders involved in the use of a psycho-active substance (as defined by the DSM-IV)
  • sensory disabling impairments, and specifically visual acuity \< 8
  • general anaesthesia during the 3 months before the study
  • pregnancy (declared by the subject)
  • persons in an emergency situation
  • persons deprived in any way of their liberty
  • use of psychotropic substance during the 3 weeks before the study
  • use of benzodiazepines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Interventions

Weights and Measures

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Giersch Anne, MD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR
  • Bonnefond Anne, PHD

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

    STUDY CHAIR

Central Study Contacts

Dimitri Sanchez

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2014

First Posted

March 17, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

September 14, 2021

Record last verified: 2021-09

Locations