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

Bipolar Disorder Clinical Trial

— DECISIDAIRE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02116400
• Other study ID #: AOI/2012/FC-02
• Secondary ID: 2012-A01673-40
• Status: Withdrawn
• Phase: N/A
• First received: April 15, 2014
• Last updated: May 23, 2016
• Start date: January 2017
• Est. completion date: July 2018

Study information

• Verified date: May 2016
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Observational

Clinical Trial 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 ").

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder
• Suicide, Attempted

Intervention

Other:
• Interview
All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)		Baseline (day 0)	No
Primary	The Iowa Gambling Task		Baseline (day 0)	No
Secondary	The Tower of London Test		Baseline (day 0)	No
Secondary	The Probabilistic Reversal Learning Task		Baseline (day 0)	No
Secondary	The Rey Osterreith Complex Figure Task		Baseline (day 0)	No
Secondary	The Baron-Cohen Test		Baseline (day 0)	No
Secondary	Serum concentration for divalproate (mg/l)		Baseline (day 0)	No
Secondary	Serum concentration for lithium (mEq/l)		Baseline (day 0)	No