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Feeling of Being in Control of One's Own Action

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ClinicalTrials.gov Identifier: NCT01312649
Recruitment Status : Active, not recruiting
First Posted : March 11, 2011
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Schizophrenia Bipolar Disorders Behavioral: Experimental psychology methods (computer tests)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : April 2011
Primary Completion Date : June 2017
Estimated Study Completion Date : December 30, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01312649


Locations
France
Pôle de Psychiatrie - Hôpital civil
Strasbourg, France
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Study Director: Anne GIERSCH, MD Hôpitaux Universitaires de Strasbourg
More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01312649     History of Changes
Other Study ID Numbers: 4880
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders