NCT02116400

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 ").

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
2.7 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

June 18, 2026

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

April 15, 2014

Last Update Submit

June 17, 2026

Conditions

Bipolar Disorder

Keywords

Suicidal ideation

Outcome Measures

Primary Outcomes (2)

  • Columbia-Suicide Severity Rating Scale (C-SSRS)

    Baseline (day 0)

  • The Iowa Gambling Task

    Baseline (day 0)

Secondary Outcomes (6)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

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: InterviewOther: Neuropsychological testingBiological: 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: InterviewOther: Neuropsychological testingBiological: Serum concentration of lithium or sodium divalproate.

Interventions

InterviewOTHER

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

Not suicidalSuicidal
Neuropsychological testingOTHER

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

Not suicidalSuicidal
Serum concentration of lithium or sodium divalproate.BIOLOGICAL

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

Not suicidalSuicidal

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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 prescribed a mood stabilizer based on lithium or divalproex.

You may not qualify if:

  • 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 does not meet euthymic criteria (score \<= 7 on the HDRS questionnaire and score \<= 7 on the YMRS questionnaire).
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Leftover serum samples will be stored in the Nîmes University Hospital Biothèque.

MeSH Terms

Conditions

Bipolar DisorderSuicidal Ideation

Interventions

Interviews as TopicNeuropsychological Tests

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Fabienne Cyprien, MD

    CHRU de Nîmes - Hôpital Universitaire Carémeau

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2014

First Posted

April 16, 2014

Study Start

January 1, 2017

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

June 18, 2026

Record last verified: 2016-05