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Bipolar Disorderi-TCPNCT02794129

fMRI of Flight of Ideas in Bipolar Disorder

A study testing Functional Magnetic Resonance Imaging in people with Bipolar Disorder, run by CHU de Reims at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder
What is being tested?
Functional Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteFrance
Study dates
Aug 2013to Sep 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • Healthy Controls (HC):
  • Men or women, right-handed
  • aged from 18 to 65 years-old
  • Native French speaker
  • Affiliated to the social security

Who cannot join

  • 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:
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Reims

    Reims, 51092

Other trials in France

About this study

Official title: Functional Magnetic Resonance Imaging of Formal Thought Disorders in Bipolar Disorder

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.

Read the detailed description

Bipolar disorder is a mental disease characterized by mood dysregulation and arises from manic, depressive or mixed episodes. During these episodes, formal thought disorders are observed, associated to emotional perturbation, behaviour troubles and some psychotic symptoms. During mania, the type of thought disorders observed are derailment, flight of ideas, with an increase in the amount of spontaneous speech and loss of goal. These observations of the patient's speech and language behaviour probably result from an underlying disturbance in semantic networks dealing with semantic associations. These networks have been studied extensively in schizophrenia but remain unknown in bipolar disorder. In this context, the aim of our study will be to have a better comprehension of formal thought disorders in bipolar disorder by cognitive exploration of semantic activation and inhibition.

Being tested
Functional Magnetic Resonance Imaging
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Magnetic Resonance ImagingOther

Study groups in NCT02794129
Study groupRoleWhat they receive
Bipolar Disorder patientsExperimentalNot described
Receives: Other: Functional Magnetic Resonance Imaging
Healthy ControlsExperimentalNot described
Receives: Other: Functional Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. brain activation profiles by Functional Magnetic Resonance Imaging

    Measured: inclusion visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2016 (estimated)
  2. Study startAug 2013
  3. Primary completionApr 2018
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02794129
Sponsor's protocol ID
PJ12075
Acronym
i-TCP
Status last verified
May 2016
First submitted
30 May 2016
Last updated
21 Jan 2026
Results posted
No

Publications

  • 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.

    PubMed 29670548

Questions about this trial

What is this clinical trial studying?

A study testing Functional Magnetic Resonance Imaging in people with Bipolar Disorder, run by CHU de Reims at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

brain activation profiles by Functional Magnetic Resonance Imaging (time frame: inclusion visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02794129, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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