NCT04237610

Brief Summary

Bipolar disorder (BD) represents a chronic mood disorder and one of the leading causes of disability worldwide. Complexity of its clinical presentations leads to delayed diagnosis and difficult management in routine clinical settings. Whereas distinguishing BD-I and BD-II main subtypes has a significant relevance for treatment strategy and for outcome, there are currently no clinical determinants of the BD subtype which could be used as early diagnostic predictors.

  • While neurobiological specificity of each BD subtype is still controversial, available evidence suggest different dopaminergic abnormalities in each subtype. Dopaminergic function is involved in decision making and reward processing which may represent useful BD subtype markers.
  • This study aims at assessing decision making during appetitive and punitive reinforcement learning in patients with BD I and BD II subtypes compared to healthy controls

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
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

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 10, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

February 24, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2022

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

January 10, 2020

Last Update Submit

September 3, 2020

Conditions

Keywords

reinforcement learning

Outcome Measures

Primary Outcomes (1)

  • Response performance in reward and loss trials

    percentage of correct responses in the probabilistic learning task

    one day visit

Study Arms (3)

Bipolar disorder type I

Behavioral: behavioral assessment

Bipolar disorder type II

Behavioral: behavioral assessment

healthy controls

Behavioral: behavioral assessment

Interventions

Probabilistic learning task

Bipolar disorder type IBipolar disorder type IIhealthy controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bipolar disorder, type I and II, in a inter critical phase (euthymic period defined by the mood scales scores mentioned in the inclusion criteria)

You may qualify if:

  • bipolar disorder (BD) type I or II, according to DSM (Diagnostic and Statistical Manual)-5 criteria
  • Montgomery and Asberg Depression Rating Scale (MADRS) score \< 15
  • Young Mania Rating Scale (YMRS) score \< 12

You may not qualify if:

  • other main diagnosis than bipolar disorder
  • other medical condition leading to cognitive deterioration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Mircea POLOSAN, MD, PhD

CONTACT

Arnaud POUCHON, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 23, 2020

Study Start

February 24, 2020

Primary Completion

February 23, 2022

Study Completion

February 23, 2022

Last Updated

September 4, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations