NCT02572674

Brief Summary

Study in 400 patients with bipolar disorder I or II, of relapse risk factors. The principal objective of this research is to test the predictive value of core vulnerability dimensions such as affective instability and emotional reactivity, measured by validated questionnaires (AIM and ALS) on recurrence of affective major episode (depressed, hypomanic or manic) during a 24 months prospective follow-up. In addition, several arguments suggest that inter-individual variability in the risk of relapse is influenced by genetic factors. In particular, the implication of such factors have been demonstrated in rapid cycling or antidepressants induced mania. However, this has never been tested in cohorts followed prospectively. Finally, the existence of neuropsychological deficits in bipolar disorder is well documented and their role in the risk of relapse is suspected. Yet the nature of these deficits, their origin and evolutionary course remain poorly investigated. In summary, the secondary objectives of this research are the study of the influence of these other clinical, neuropsychological and genetic factors on the risk of relapse.

  • Main objective of the project To determine if the scores of AIM and ALS, assessed at baseline in euthymic bipolar patients is associated with relapse in patients during a 2 years follow-up period.
  • Secondary objectives of the project Determine if the neuropsychological performance at T0, measured in euthymic patients predict relapse during a 2 years follow-up period. Determine whether the neuropsychological deficits observed in euthymic bipolar patients that contribute to functional impairment worsen with time. DNA collection to test the involvement of candidate genes Serum collection to study the biological and infectious biomarkers
  • Methodology Prospective follow up studies. Multicenter.

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
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

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, 2010

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

6.3 years

First QC Date

August 13, 2015

Last Update Submit

June 19, 2017

Conditions

Bipolar DisorderEuthymic State

Keywords

Bipolar disorderrelapse risk factorsprospective follow up

Outcome Measures

Primary Outcomes (1)

  • Combined outcome based on AIM and ALS's score assessed at baseline in euthymic bipolar patients associated with relapse in patients during a 2 years follow-up period.

    24 months

Secondary Outcomes (2)

  • Global neuropsychological performance based on combined score of all neuropsychological scales (detail below) at T0, measured in euthymic patients predict relapse during a 2 years follow-up period.

    24 months

  • Global neuropsychological deficits based on combined score of all neuropsychological scales (detail below) observed in euthymic bipolar patients that contribute to functional impairment worsen with time

    24 months

Study Arms (1)

experimental arm

OTHER

Experimental follow up : Neuropsychological assessment at 6 month and genetic samples

Other: Experimental follow upGenetic: Genetic sample

Interventions

Experimental follow upOTHER

Neuropsychological assessment (intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function)

experimental arm
Genetic sampleGENETIC

Blood samples

experimental arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bipolar disorder I or II
  • French language
  • Aging between 18 years and 55 years
  • Young Mania Rating Scale (YMRS) \< 12
  • Montgomery Asberg Depression Rating Scale (MDRS) \< 10

You may not qualify if:

  • Rapid cycling
  • Undefined number of major relapses
  • Drug and alcohol abuse within 6 months
  • Electroconvulsive therapy (ECT) within 12 months
  • Epilepsy, traumatism cranial or other neurological diseases
  • Daltonism or visual trouble

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fernand Widal Hospital

Paris, 75010, France

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Frank BELLIVIVIER, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

October 9, 2015

Study Start

May 1, 2010

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

June 20, 2017

Record last verified: 2017-06

Locations

FR(1)