Reward and Punishment Sensitivity in Bipolar Disorders (Recodec-BP)

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

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder
• Intervention / Treatment: Behavioral: behavioral assessment

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Grenoble Cedex 9, France, 38043
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: Polosan Mircea; Phone Number: 0033476765414; Email: mpolosan@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response performance in reward and loss trials	percentage of correct responses in the probabilistic learning task	one day visit

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Anticipated): February 23, 2022
• Study Completion (Anticipated): February 23, 2022

Study Registration Dates

• First Submitted: January 10, 2020
• First Submitted That Met QC Criteria: January 17, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: reinforcement learning
• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Bipolar Disorder
• Other Study ID Numbers: 38RC18.171; 2018-A01962-53 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No