Clinical trial NCT02116400: Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
Official title: Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bipolar Disorder
Keywords: Suicidal ideation
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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 ").

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* The patient was correctly informed about the study
* The patient must be insured or beneficiary of a health insurance plan
* The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC
* The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score \<= 7 on the HDRS questionnaire and score \<= 7 on the YMRS questionnaire).
* The patient is prescribed a mood stabilizer based on lithium or divalproex.

Exclusion Criteria:

* The patient is under judicial protection, under tutorship or curatorship
* The patient formalizes his/her opposition to the studyd
* It is impossible to correctly inform the patient
* The patient has mental retardation
* The patient has practiced substance abuse or dependence within the 6 months prior to study inclusion (alcool, cannabis, opiates, psychostimulants)
* The patient does not meet euthymic criteria (score \<= 7 on the HDRS questionnaire and score \<= 7 on the YMRS questionnaire).

Uninclusion Criteria:

* The patients withdraws consent during the study
* The patient does not understand directions necessary for the neurpsychological tasks
* The patient is not able to use a computer to complete the neuropsychological tasks

Primary outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (day 0)
measure: The Iowa Gambling Task
timeFrame: Baseline (day 0)
Secondary outcomes:
measure: The Tower of London Test
timeFrame: Baseline (day 0)
measure: The Probabilistic Reversal Learning Task
timeFrame: Baseline (day 0)
measure: The Rey Osterreith Complex Figure Task
timeFrame: Baseline (day 0)
measure: The Baron-Cohen Test
timeFrame: Baseline (day 0)
measure: Serum concentration for divalproate (mg/l)
timeFrame: Baseline (day 0)
measure: Serum concentration for lithium (mEq/l)
timeFrame: Baseline (day 0)
Other outcomes:
Locations:
Study officials:
affiliation: CHRU de Nîmes - Hôpital Universitaire Carémeau
name: Fabienne Cyprien, MD
role: PRINCIPAL_INVESTIGATOR
References: