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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02116400
Acronym
DECISIDAIRE
Enrollment
0
Registered
2014-04-16
Start date
2017-01-01
Completion date
2018-07-01
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Suicidal ideation

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.

Interventions

OTHERInterview

All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.

OTHERNeuropsychological testing

Neuropsychological tests are administered (requires computer use). See endpoints.

BIOLOGICALSerum concentration of lithium or sodium divalproate.

Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Columbia-Suicide Severity Rating Scale (C-SSRS)Baseline (day 0)
The Iowa Gambling TaskBaseline (day 0)

Secondary

MeasureTime frame
The Tower of London TestBaseline (day 0)
The Probabilistic Reversal Learning TaskBaseline (day 0)
The Rey Osterreith Complex Figure TaskBaseline (day 0)
The Baron-Cohen TestBaseline (day 0)
Serum concentration for divalproate (mg/l)Baseline (day 0)
Serum concentration for lithium (mEq/l)Baseline (day 0)

Contacts

PRINCIPAL_INVESTIGATORFabienne Cyprien, MD

CHRU de Nîmes - Hôpital Universitaire Carémeau

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026