Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt

Withdrawn

• Conditions: Bipolar Disorder
• Interventions: Other: Interview; Other: Neuropsychological testing; Biological: Serum concentration of lithium or sodium divalproate.

• Registration Number: NCT02116400
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2014-04-15
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Study Start: 2017-01
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Not suicidal	Interview	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.
Suicidal	Neuropsychological testing	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.
Suicidal	Serum concentration of lithium or sodium divalproate.	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.
Suicidal	Interview	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	Neuropsychological testing	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.
Not suicidal	Serum concentration of lithium or sodium divalproate.	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.

Primary Outcome Measures

Name	Time	Method
The Iowa Gambling Task	Baseline (day 0)
Columbia-Suicide Severity Rating Scale (C-SSRS)	Baseline (day 0)

Secondary Outcome Measures

Name	Time	Method
The Tower of London Test	Baseline (day 0)
The Rey Osterreith Complex Figure Task	Baseline (day 0)
Serum concentration for lithium (mEq/l)	Baseline (day 0)
The Probabilistic Reversal Learning Task	Baseline (day 0)
The Baron-Cohen Test	Baseline (day 0)
Serum concentration for divalproate (mg/l)	Baseline (day 0)