NCT02794129

Brief Summary

Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. The observations of the patient's speech and language behaviour due to flight of ideas or loss of goal probably result from an underlying disturbance in semantic networks dealing with semantic associations. The aim of our study will be to have a better comprehension of thought disorders in bipolar disorder by cognitive exploration of semantic processing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2013

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 21, 2026

Status Verified

May 1, 2016

Enrollment Period

4.7 years

First QC Date

May 30, 2016

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • brain activation profiles by Functional Magnetic Resonance Imaging

    inclusion visit

Study Arms (2)

Bipolar Disorder patients

EXPERIMENTAL
Other: Functional Magnetic Resonance Imaging

Healthy Controls

EXPERIMENTAL
Other: Functional Magnetic Resonance Imaging

Interventions

Bipolar Disorder patientsHealthy Controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BD patients :
  • Men or women, right-handed
  • diagnosis of type 1 bipolar disorder, according to the DSM-IV criteria
  • aged from 18 to 65 years-old
  • Native French speaker
  • Affiliated to the social security
  • Healthy Controls (HC):
  • Men or women, right-handed
  • aged from 18 to 65 years-old
  • Native French speaker
  • Affiliated to the social security

You may not qualify if:

  • BD patients :
  • recent alcohol and/or drug abuse or dependence
  • significant general medical illness, including neurological disorders or head trauma
  • sensorial impairment (visual and/or hearing)
  • Contraindication to the use of MRI
  • HC:
  • first-degree-relative history of bipolar disorder, schizophrenia or schizoaffective disorder according to DSM-IV
  • recent alcohol and/or drug abuse or dependence
  • significant general medical illness, including neurological disorders or head trauma
  • sensorial impairment (visual and/or hearing)
  • Contraindication to the use of MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

  • Raucher-Chene D, Terrien S, Gierski F, Obert A, Caillies S, Besche-Richard C, Kaladjian A. Neural Correlates of Semantic Inhibition in Relation to Hypomanic Traits: An fMRI Study. Front Psychiatry. 2018 Apr 4;9:108. doi: 10.3389/fpsyt.2018.00108. eCollection 2018.

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

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

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 8, 2016

Study Start

August 1, 2013

Primary Completion

April 1, 2018

Study Completion

September 1, 2018

Last Updated

January 21, 2026

Record last verified: 2016-05

Locations