Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide At… (NCT02116400) | Clinical Trial Compass
WithdrawnNot Applicable
Neuropsychological Characterization of Patients With Bipolar Disorder and a History of Suicide Attempt
Stopped: The primary investigator moved.
0Started 2017-01
Plain-language 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 ").
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'withdrawn' — can you tell me if there's a similar active study looking at suicide risk and decision-making in bipolar disorder that I might be eligible to learn more about?
2The trial planned to use something called the Iowa Gambling Task, which measures decision-making under risk — can you explain what that kind of neuropsychological testing might tell us about how bipolar disorder affects my thinking, and whether that information would be useful for my own care?
3The study focused specifically on people with bipolar disorder who have a history of suicide attempts — given my own history, are there other research studies or clinical programs that take a similar approach to understanding suicide risk that you'd recommend I look into?
4Since this trial was withdrawn before it could collect data, what do we currently know about the relationship between bipolar disorder and suicide risk, and how does that shape the way you'd approach monitoring and treatment for me?
5The trial planned to use the Columbia Suicide Severity Rating Scale as a key measure — is that a tool your team already uses to track my risk over time, and if not, would it be worth incorporating into my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.