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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-A01673-40 | Other Identifier | RCB number |
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The primary investigator moved.
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The main objective of this study is to evaluate decision-making using the Iowa Gambling Task (IGT) among patients with euthymic bipolar disorder according to their personal history of suicide attempt ("suicidal" vs. "not suicidal ").
The secondary objectives of this study are:
A. Evaluate other aspects of cognitive functioning (using the Tower of London, the Probabilistic Reversal-learning task, the Rey Complex Figure, the Reading the Mind in the Eyes test) in euthymic patients with bipolar disorder, depending on the presence or absence of a history of suicide attempt; B. Explore performance on neuropsychological tests depending on the type of therapy administered (lithium salts or valproate monotherapy or in combination with other mood stabilizers); C. Explore a possible relationship between circulating levels of lithium or sodium divalproex results and different neuropsychological tests; D. Establishment of a biobank for this population with leftover blood samples following serum lithium or divalproex testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suicidal | Patients in this group have had suicidal behaviour according to the C-SSRS score. Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate. |
| |
| Not suicidal | Patients in this group have not had suicidal behaviour according to the C-SSRS score. Intervention: Interview Intervention: Neuropsychological testing Intervention: Serum concentration of lithium or sodium divalproate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interview | Other | All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints. |
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| Measure | Description | Time Frame |
|---|---|---|
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline (day 0) | |
| The Iowa Gambling Task | Baseline (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| The Tower of London Test | Baseline (day 0) | |
| The Probabilistic Reversal Learning Task | Baseline (day 0) | |
| The Rey Osterreith Complex Figure Task |
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Inclusion Criteria:
Exclusion Criteria:
Uninclusion Criteria:
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Patients are recruited via the Bipolar Expert Centres (BEC) at the participating hospitals. Euthymic bipolar patients requiring a lithium or divalproex -based mood stabilizer will be included.
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne Cyprien, MD | CHRU de Nîmes - Hôpital Universitaire Carémeau | Principal Investigator |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D009483 | Neuropsychological Tests |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Leftover serum samples will be stored in the Nîmes University Hospital Biothèque.
| Neuropsychological testing | Other | Neuropsychological tests are administered (requires computer use). See endpoints. |
|
| Serum concentration of lithium or sodium divalproate. | Biological | Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate. |
|
| Baseline (day 0) |
| The Baron-Cohen Test | Baseline (day 0) |
| Serum concentration for divalproate (mg/l) | Baseline (day 0) |
| Serum concentration for lithium (mEq/l) | Baseline (day 0) |
| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |