Feeling of Being in Control of One's Own Action

This study is currently recruiting participants.
Verified December 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01312649
First received: March 1, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

The investigators aim is to understand the cognitive mechanisms that contribute to the emergence of delusions of control (the belief that one's own actions or thoughts are controlled by an external force). These symptoms are mainly encountered in patients with schizophrenia, and the investigators will distinguish patients with schizophrenia with or without this symptom together with patients with bipolar disorder. Based on the investigators previous studies, this project will help to determine the role of two elementary mechanisms in the ability to feel in control of voluntary actions: (1) the processing of the sensory consequences of action, and (2) the ability to build mental representations for sequenced actions.


Condition Intervention
Schizophrenia
Bipolar Disorders
Behavioral: Experimental psychology methods (computer tests)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Feeling of Being in Control of One's Own Action: Which Mechanisms in Healthy Volunteers and in Mental Diseases

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Estimated Enrollment: 370
Study Start Date: April 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Healthy volunteers
Behavioral: Experimental psychology methods (computer tests)
Experimental: Arm 2
Schizophrenia with history of delusions of control
Behavioral: Experimental psychology methods (computer tests)
Experimental: Arm 3
Schizophrenia without history of delusions of control
Behavioral: Experimental psychology methods (computer tests)
Experimental: Arm 4
Bipolar disorders
Behavioral: Experimental psychology methods (computer tests)
Active Comparator: Arm 5
Matched healthy controls
Behavioral: Experimental psychology methods (computer tests)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with schizophrenia or bipolar disorders (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
  • 18-55 years old

Exclusion Criteria:

  • Past history affecting CNS
  • Invalidating sensory disorders
  • Intake of psychotropic drugs, except for patients
  • Intake of benzodiazepines
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01312649

Contacts
Contact: Anne Giersch 3.33.88.11.64.71 giersch@alsace.u-strasbg.fr

Locations
France
Pôle de Psychiatrie - Hôpital civil Recruiting
Strasbourg, France
Contact: Anne GIERSCH, MD    3.33.88.11.64.71    giersch@alsace.u-strasbg.fr   
Sub-Investigator: Gilles BERTSCHY, MD         
Sub-Investigator: Laurence LALANNE, MD         
Sub-Investigator: Sebastien WEIBEL, MD         
Principal Investigator: Anne GIERSCH, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Anne GIERSCH, MD Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01312649     History of Changes
Other Study ID Numbers: 4880
Study First Received: March 1, 2011
Last Updated: December 2, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on April 14, 2014