Bipolar DisorderRecodec-BPNCT04237610
Reward and Punishment Sensitivity in Bipolar Disorders
An observational study of Bipolar Disorder, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- behavioral assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 23 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- other main diagnosis than bipolar disorder
- other medical condition leading to cognitive deterioration
Trial locations and contacts
1 site in 1 country.
Arnaud POUCHON, MD contact
France1 site, 1 recruiting
- Recruiting
Chu Grenoble Alpes
Grenoble, 38043
Polosan Mircea, 0033476765414, mpolosan@chu-grenoble.fr
About this study
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
- Conditions
- Bipolar Disorder
- Being tested
- behavioral assessment
- Keywords
- reinforcement learning
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral assessmentBehavioural
Probabilistic learning task
| Study group | Role | What they receive |
|---|---|---|
| Bipolar disorder type I | Not described Receives: Behavioral: behavioral assessment | |
| Bipolar disorder type II | Not described Receives: Behavioral: behavioral assessment | |
| healthy controls | Not described Receives: Behavioral: behavioral assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response performance in reward and loss trials
percentage of correct responses in the probabilistic learning task
Measured: one day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start24 Feb 2020
- Primary completion23 Feb 2022 (estimated)
- Study completion23 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237610
- Sponsor's protocol ID
- 38RC18.171
- Other IDs
- 2018-A01962-53
- Acronym
- Recodec-BP
- Status last verified
- Sep 2020
- First submitted
- 10 Jan 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward and Punishment Sensitivity in Bipolar Disorders
- ClinicalTrials.gov ID
- NCT04237610
- Acronym / sponsor ID
- Recodec-BP / 38RC18.171
- Conditions
- Bipolar Disorder
- Keywords
- reinforcement learning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 23 Feb 2022 (estimated)
- Study completion
- 23 Feb 2022 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder type I | – | Behavioral: behavioral assessment |
| Bipolar disorder type II | – | Behavioral: behavioral assessment |
| healthy controls | – | Behavioral: behavioral assessment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- other main diagnosis than bipolar disorder
- other medical condition leading to cognitive deterioration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral assessmentProbabilistic learning task | Behavioural | Bipolar disorder type I, Bipolar disorder type II, healthy controls |
Primary outcome
Response performance in reward and loss trials
Time frame: one day visit
percentage of correct responses in the probabilistic learning task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud POUCHON, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mircea POLOSAN, MD, PhD (0033476765414, mpolosan@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response performance in reward and loss trials (time frame: one day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.