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Feeling of Being in Control of One's Own Action

Primary Purpose

Schizophrenia, Bipolar Disorders

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Experimental psychology methods (computer tests)

About this trial

This is an interventional basic science trial for Schizophrenia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Pôle de Psychiatrie - Hôpital civil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Healthy volunteers

Schizophrenia with history of delusions of control

Schizophrenia without history of delusions of control

Bipolar disorders

Matched healthy controls

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT01312649

First Posted

March 1, 2011

Last Updated

March 21, 2018

Sponsor

University Hospital, Strasbourg, France

1. Study Identification

Unique Protocol Identification Number

NCT01312649

Brief Title

Feeling of Being in Control of One's Own Action

Official Title

Feeling of Being in Control of One's Own Action: Which Mechanisms in Healthy Volunteers and in Mental Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

April 2011 (Actual)

Primary Completion Date

June 15, 2017 (Actual)

Study Completion Date

June 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Strasbourg, France

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Bipolar Disorders

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Healthy volunteers

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

Schizophrenia with history of delusions of control

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

Schizophrenia without history of delusions of control

Arm Title

Arm 4

Arm Type

Experimental

Arm Description

Bipolar disorders

Arm Title

Arm 5

Arm Type

Active Comparator

Arm Description

Matched healthy controls

Intervention Type

Behavioral

Intervention Name(s)

Experimental psychology methods (computer tests)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne GIERSCH, MD

Organizational Affiliation

Hôpitaux Universitaires de Strasbourg

Official's Role

Study Director

Facility Information:

Facility Name

Pôle de Psychiatrie - Hôpital civil

City

Strasbourg

Country

France

12. IPD Sharing Statement

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Feeling of Being in Control of One's Own Action

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