Feeling of Being in Control of One's Own Action
This study is currently recruiting participants.
Verified May 2013 by University Hospital, Strasbourg, France
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01312649
First received: March 1, 2011
Last updated: May 24, 2013
Last verified: May 2013
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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: | May 24, 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 June 13, 2013