Clinical trial NCT03977909: Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders Cohort
Official title: Early Maladaptative Schemas Among Euthymic Patients With Bipolar Disorder: Exploring the Relationships With Symptoms, Functioning and Cognition in the Versailles FondaMental Advanced Centers of Expertise for Bipolar Disorders
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bipolar Disorder
Keywords: Early Maladaptative Schemas
Cognition
Functioning
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
Collaborators: name: Fondation FondaMental
name: Versailles Saint-Quentin-en-Yvelines University
name: University of Bordeaux
First posted: 2019-06-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included patients recruited into the FACE-BD (FondaMental Advanced Centers of Expertise for Bipolar Disorders) cohort at Versailles Hospital. This registry was set up by the Fondation FondaMental (www.fondation-fondamental. org) which created an infrastructure and provided resources to follow clinical cohorts and comparative-effectiveness research in patients with BD.

Patients were referred by their general practitioner or by their psychiatrist.

Brief summary: Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Detailed description: Early Maladaptive Schemas (EMS) are overactivated in euthymic bipolar disorders (BD) and are associated with poor psychosocial functioning and higher suicidality. However, few studies have explored EMS in bipolar disorders, despite EMS therapy is a promising tool for the psychotherapy of BD.

This study will use the data collected at the Versailles Expert Center for Bipolar disorder, in the local FACE-BD registry. These data will be collected at the inclusion, 12 months and 24 months later. They included an extensive neuropsychological battery and an extensive evaluation of the clinical characteristics of bipolar disorder. EMS will be measured with the Young Schema Questionnaire Short Form 3.

The first objective of this study is to establish different clusters of EMS in euthymic bipolar disorders, compare these clusters according to the clinical characteristics of BD and neuropsychological performances and evaluate the temporal stability of these clusters at 12 and 24 months.

The second objective of this study is to quantify the impact of EMS on functioning in euthymic BD, beyond the effect of cognition and residual depressive symptoms.

Eligibility criteria: Inclusion Criteria:

- bipolar disorder according to DSM IV-R (structured clinical interview)

Exclusion Criteria:

* major depressive or manic or hypomanic during the evaluation
* Montgomery Åsberg Depression Rating Scale ⩽10
* Young Mania Rating Scale ⩽12

Primary outcomes:
measure: Early Maladaptative Schemas T0
timeFrame: 18 measures by subject, assessed at inclusion
measure: Early Maladaptative Schemas T12
timeFrame: 18 measures by subject, assessed at 12 months
measure: Early Maladaptative Schemas T24
timeFrame: 18 measures by subject, assessed at inclusion 24 months
Secondary outcomes:
measure: functioning
timeFrame: one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)
measure: Depression
timeFrame: one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)
measure: Cognition
timeFrame: 5 measures by subject, assessed 2 times (at inclusion and 24 months)
measure: Hypomania
timeFrame: one measure by subject, assessed 3 times (inclusion, 12 months and 24 months)
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: Paul ROUX
Study officials:
References:
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citation: Roux P, Raust A, Cannavo AS, Aubin V, Aouizerate B, Azorin JM, Bellivier F, Belzeaux R, Bougerol T, Cussac I, Courtet P, Etain B, Gard S, Job S, Kahn JP, Leboyer M, Olie E; FondaMental Advanced Centers of Expertise in Bipolar Disorders (FACE-BD) Collaborators; Henry C, Passerieux C. Associations between residual depressive symptoms, cognition, and functioning in patients with euthymic bipolar disorder: results from the FACE-BD cohort. Br J Psychiatry. 2017 Dec;211(6):381-387. doi: 10.1192/bjp.bp.117.201335. Epub 2017 Oct 19.
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