Recodec-BP: Reward and Punishment Sensitivity in Bipolar Disorders

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Recruiting

CT.gov ID

NCT04237610

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Behavioral: behavioral assessment

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Reward and Punishment Sensitivity in Bipolar Disorders

Actual Study Start Date :

Feb 24, 2020

Anticipated Primary Completion Date :

Feb 23, 2022

Anticipated Study Completion Date :

Feb 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Bipolar disorder type I	Behavioral: behavioral assessment Probabilistic learning task
Bipolar disorder type II	Behavioral: behavioral assessment Probabilistic learning task
healthy controls	Behavioral: behavioral assessment Probabilistic learning task

Arm

Intervention/Treatment

Bipolar disorder type I

Behavioral: behavioral assessment

Probabilistic learning task

Bipolar disorder type II

Behavioral: behavioral assessment

Probabilistic learning task

healthy controls

Behavioral: behavioral assessment

Probabilistic learning task

Outcome Measures

Primary Outcome Measures

Response performance in reward and loss trials [one day visit]
percentage of correct responses in the probabilistic learning task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Grenoble Alpes	Grenoble Cedex 9		France	38043

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT04237610

Other Study ID Numbers:

38RC18.171
2018-A01962-53

First Posted:

Jan 23, 2020

Last Update Posted:

Sep 4, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Grenoble

reinforcement learning

Additional relevant MeSH terms:

Bipolar Disorder

Study Results

No Results Posted as of Sep 4, 2020