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

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 ").

Study Overview

• Status: Withdrawn
• Conditions: Bipolar Disorder
• Intervention / Treatment: Other: Interview; Other: Neuropsychological testing; Biological: Serum concentration of lithium or sodium divalproate.

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Interview; All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.; Other: Neuropsychological testing; Neuropsychological tests are administered (requires computer use). See endpoints.; Biological: Serum concentration of lithium or sodium divalproate.; Venous blood is drawn and tested for 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.	Other: Interview; All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.; Other: Neuropsychological testing; Neuropsychological tests are administered (requires computer use). See endpoints.; Biological: Serum concentration of lithium or sodium divalproate.; Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Columbia-Suicide Severity Rating Scale (C-SSRS)	Baseline (day 0)
The Iowa Gambling Task	Baseline (day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
The Tower of London Test	Baseline (day 0)
The Probabilistic Reversal Learning Task	Baseline (day 0)
The Rey Osterreith Complex Figure Task	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)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Fabienne Cyprien, MD, CHRU de Nîmes - Hôpital Universitaire Carémeau

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Estimate): May 24, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Suicidal ideation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Bipolar and Related Disorders; Self-Injurious Behavior; Bipolar Disorder; Suicide; Suicide, Attempted; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: AOI/2012/FC-02; 2012-A01673-40 (Other Identifier: RCB number)