NCT02036606

Brief Summary

Racing thoughts relate to subjective acceleration of thinking which has been essentially associated with manic episodes in bipolar disorder. Qualitatively, the phenomenology of racing thoughts in major depression seems to differ from rumination and pure manic racing thoughts: thoughts of all kinds accumulate in the patient's head. Recent qualitative evidence is consistent with the existence of these two kinds of "thought overactivity" related to mood disorders. In order to evaluate this and better understand the psychopathological and cognitive mechanisms that underlie thought overactivity in mood disorders, we have created a 34-item self-questionnaire - the Racing and Crowded Thoughts Questionnaire (RCTQ) and a number of neuropsychological tasks (time perception, cognitive flexibility). Also, given the relationship between mood disorders and creativity, it is likely that thought overactivity is related to increased creativity. We aim at evaluating this relationship through the French version of the Cognitive Processes Associated with Creativity scale (CPAC).

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
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

5 years

First QC Date

January 6, 2014

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Validation of the scale of Crowded Racing Thoughts Questionary = (RCTQ scale that assesses the two forms of racing thoughts)

    Demonstrated a two-factor structure (crowded and racing) assessment concurrent and discriminant validity.

    one week

Secondary Outcomes (1)

  • Evaluation of executive and temporal mechanisms involved in racing thoughts

    one week

Other Outcomes (1)

  • Validation of the French version of the scale Cognitive Processes Associated with Creativity or CPAC scale (scale that assesses creativity)

    one week

Study Arms (2)

mood disorders

Questionary and neuropsychological tasks will be administered

Behavioral: questionary

control

Questionary and neuropsychological tasks will be administered

Behavioral: questionary

Interventions

questionaryBEHAVIORAL
controlmood disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • Bipolar disorder or depressive disorder
  • years old

You may not qualify if:

  • neurological conditions or sequelae
  • substance abuse in the last 10 months
  • schizophrenia
  • ADHD
  • Borderline personality disorder
  • Pregnant women- Subjects under legal supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie 2 , Les Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67091, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Gilles Bertschy, PHDMD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitri Sanchez

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2014

First Posted

January 15, 2014

Study Start

April 1, 2014

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations