NCT02793518

Brief Summary

Self-defining memories (SDMs) are memories that are still important today to understand who the investigators are and participate to the maintain of personal identity. SDMs are also linked to our capacity to project ourselves into the future. In bipolar disorder, life events play an important role in the course and outcome of the disease. the study is the first to investigate SDMs and self-defining future projections in a population of remitted patients with bipolar disorder.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 12, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 8, 2016

Status Verified

May 1, 2016

Enrollment Period

3.4 years

First QC Date

May 12, 2016

Last Update Submit

June 7, 2016

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

  • psychological test : Mini International Neuropsychiatric Interview (M.I.N.I.)

    Day 01

  • psychological test : State - Trait Anxiety Inventory Form Y

    day 15

  • psychological test : Hamilton Depression Scale (HAM-D)

    Day 01

  • psychological test : Mill Hill Vocabulary Scale

    day 15

Study Arms (2)

Bipolar Disorder patients

EXPERIMENTAL
Behavioral: psychological tests

Healthy Controls

EXPERIMENTAL
Behavioral: psychological tests

Interventions

psychological testsBEHAVIORAL
Bipolar Disorder patientsHealthy Controls

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, France, 51092, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Central Study Contacts

Delphine RAUCHER-CHENE

CONTACT

draucherchene@chu-reims.fr

Sarah BARRIERE

CONTACT

sbarriere@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2016

First Posted

June 8, 2016

Study Start

May 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-05

Locations

FR(1)