Bipolar DisorderDECISIDAIRENCT02116400
Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
An observational study of Bipolar Disorder, run by Centre Hospitalier Universitaire de Nīmes.
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 "). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Interview, Neuropsychological testing and Serum concentration of lithium or sodium divalproate.
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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
About this study
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 ").
Read the detailed description
The secondary objectives of this study are:
- 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.
- Conditions
- Bipolar Disorder
- Being tested
- Interview, Neuropsychological testing, Serum concentration of lithium or sodium divalproate.
- Keywords
- Suicidal ideation
- Medical subject headings
- Bipolar Disorder, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.
Neuropsychological testingOther
Neuropsychological tests are administered (requires computer use). See endpoints.
Serum concentration of lithium or sodium divalproate.Biological
Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: Neuropsychological testing; Biological: 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. Receives: Other: Interview; Other: Neuropsychological testing; Biological: Serum concentration of lithium or sodium divalproate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Baseline (day 0)
The Iowa Gambling Task
Measured: Baseline (day 0)
Secondary outcomes (6)
The Tower of London Test
Measured: Baseline (day 0)
The Probabilistic Reversal Learning Task
Measured: Baseline (day 0)
The Rey Osterreith Complex Figure Task
Measured: Baseline (day 0)
The Baron-Cohen Test
Measured: Baseline (day 0)
Serum concentration for divalproate (mg/l)
Measured: Baseline (day 0)
Serum concentration for lithium (mEq/l)
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJan 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Why it stopped: The primary investigator moved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Cyprien, MD, Principal investigator, CHRU de Nîmes - Hôpital Universitaire Carémeau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116400
- Sponsor's protocol ID
- AOI/2012/FC-02
- Other IDs
- 2012-A01673-40
- Acronym
- DECISIDAIRE
- Status last verified
- May 2016
- First submitted
- 15 Apr 2014
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
- ClinicalTrials.gov ID
- NCT02116400
- Acronym / sponsor ID
- DECISIDAIRE / AOI/2012/FC-02
- Conditions
- Bipolar Disorder
- Keywords
- Suicidal ideation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The primary investigator moved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suicidal | – | Other: Interview, Other: Neuropsychological testing, Biological: 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. |
| Not suicidal | – | Other: Interview, Other: Neuropsychological testing, Biological: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAll patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints. | Other | Not suicidal, Suicidal |
| Neuropsychological testingNeuropsychological tests are administered (requires computer use). See endpoints. | Other | Not suicidal, Suicidal |
| Serum concentration of lithium or sodium divalproate.Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate. | Biological | Not suicidal, Suicidal |
Primary outcome
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline (day 0)
The Iowa Gambling Task
Time frame: Baseline (day 0)
6 secondary outcomes
The Tower of London Test
Time frame: Baseline (day 0)
The Probabilistic Reversal Learning Task
Time frame: Baseline (day 0)
The Rey Osterreith Complex Figure Task
Time frame: Baseline (day 0)
The Baron-Cohen Test
Time frame: Baseline (day 0)
Serum concentration for divalproate (mg/l)
Time frame: Baseline (day 0)
Serum concentration for lithium (mEq/l)
Time frame: Baseline (day 0)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Cyprien, MD principal investigator
CHRU de Nîmes - Hôpital Universitaire Carémeau
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Centre Hospitalier Universitaire de Nīmes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia-Suicide Severity Rating Scale (C-SSRS) (time frame: Baseline (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.