- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02793518
Mental Time Travel and Identity in Bipolar Disorder Patients
Self-defining Memories and Future Projections in Bipolar Disorder Patients
Study Overview
Detailed Description
Study design: case / control study in inclusion prospective, single center. population:
- A group of 30 patients aged 18 to 60 years and followed in the psychiatry department of adult CHU Reims for bipolar disorder type I (DSM-IV criteria).
- A group of 30 control subjects with no personal or family history of severe psychiatric disorder (bipolar disorder, schizophrenia or schizoaffective disorder), recruited from the staff of the University Hospital of Reims, the medical faculty of Reims or Marnais center health promotion of Reims, via the intranet and paper display.
The two groups will be matched for age (± 3 years), sex and educational level (± 2 years).
Plan of investigation: the study will be done in two visits:
The first visit by a psychiatrist for:
- information on the objectives and the methods of research, verification criteria for inclusion and non-inclusion and participation of obtaining consent (written consent)
- comprehensive psychiatric evaluation and procurement different scales (anxiety scale, Hamilton depression scale, evaluation of verbal IQ, ...).
- 2nd visit, a maximum of 15 days after the first visit by a psychologist, neuropsychologist for the award of the memories of love and future projections defining self: the experimenter asks the subjects to relate memories 3 and 3 future projections. It is important personal events that arouse strong emotions and that the subjects often think.
Memories and projections reported by the subjects are then classified according to their emotional valence, their content, significance and degree of integration itself.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reims, France, 51092
- Recruiting
- CHU Reims
-
Contact:
- Delphine RAUCHER-CHENE
-
Contact:
- Sarah BARRIERE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
BD patients :
- Men or women, right-handed, with a diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria, aged from 18 to 60 years-old
- Native French speaker
- Affiliated to the social security
- Accepting the study after reading the information note and signing the consentment form
Healthy Controls (HC):
- Men or women, right-handed, aged from 18 to 65 years-old
- Native French speaker
- Affiliated to the social security
- Accepting the study after reading the information note and signing the consentment form
Exclusion criteria
BD patients :
- A recent alcohol and/or drug abuse or dependence
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment (visual and/or hearing)
HC:
- A personal or first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
- A recent alcohol and/or drug abuse or dependence
- A significant general medical illness, including neurological disorders or head trauma
- A sensorial impairment (visual and/or hearing)
Study Plan
How is the study designed?
Design Details
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Healthy Controls
|
|
|
EXPERIMENTAL: Bipolar Disorder patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
psychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)
Time Frame: Day 01
|
Day 01
|
|
psychological test : State - Trait Anxiety Inventory Form Y
Time Frame: day 15
|
day 15
|
|
psychological test : Hamilton Depression Scale (HAM-D)
Time Frame: Day 01
|
Day 01
|
|
psychological test : Mill Hill Vocabulary Scale
Time Frame: day 15
|
day 15
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA12064
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.