Seroquel ® in Patients With Bipolar Disorder in Remission With Signs of Impaired Impulse Control (NCT05098353) | Clinical Trial Compass
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Seroquel ® in Patients With Bipolar Disorder in Remission With Signs of Impaired Impulse Control
Russia30 participantsStarted 2021-04-10
Plain-language summary
In this study, the task was to evaluate the effectiveness of prescribing small doses of quetiapine (25-75 mg) for bipolar patients in remission in order to relieve symptoms of impulsivity.
Who can participate
Age range
18 Years – 65 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
. Availability of written informed consent to participate in the Program.
. The established diagnosis of bipolar disorder in incomplete remission and the presence of violations in the field of impulse control (score on the Barratt scale above 70 points)
. Age from 18 to 65 years inclusive;
. The patient's desire and ability to participate in the study and follow the doctor's instructions.
Exclusion criteria
. The presence of quetiapine intolerance in the anamnesis.
. The presence of an actual active phase of bipolar disorder: depression (MADRS score above 22 points) or mania (YMRS score above 20 points).
. Hypersensitivity to the components of quetiapine in the anamnesis;
. Current clinically significant and unstable somatic diseases.
. Participation in other observational programs or clinical trials during the conduct of this study.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Statistically significant changes in Barratt Impulsiveness Scale
Timeframe: 6 weeks of treatment
2
Statistically significant changes in total earnings score of Ballon Analog Risk Task (BART)
Timeframe: 6 weeks of treatment
3
Statistically significant changes in dprime parameter in Go-no-Go task
Timeframe: 6 weeks of treatment
Trial details
NCT IDNCT05098353
SponsorFederal Stare Budgetary Scientific Institution, Mental Health Research Center