Seroquel ® in Patients With Bipolar Disorder in Remission With Signs of Impaired Impulse Control
NCT ID: NCT05098353
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-04-10
2021-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The method of administration, dosage regimen and duration of taking quetiapine in this study: 1-3 tablets from one to 3 times a day, regardless of food intake for 28 days.
Each patient included in the program will be given a package with the drug for 14 days of admission. In the first 14 days of administration, dose adjustment is possible in the range from 25 to 75 mg, depending on individual tolerability. The decision on correction is made by the doctor based on a phone call to the patient after the first week of taking the drug at a dose of 25 mg. Correction is also possible at a later or earlier date during the first two weeks of therapy. At visit 2, the patient will have to provide the doctor with a package of the drug as part of the compliance assessment. At visit 2, the doctor should give the patient packages with the drug for 28 days of admission and ask them to bring packages to assess compliance and account for the drug for visit 3.
Screening (Visit 1 / Day 0) The inclusion of the subject in the program will be carried out on the basis of an assessment of demographic, clinical characteristics, anamnesis data. Prior to the start of the examination, the subject must be provided with oral information about the nature of the study, an informed consent form for signing.
The following procedures will be performed during the screening:
* Collection of demographic data;
* Medical history (previous and concomitant diseases, surgical interventions, allergic history, gynecological history);
* Confirmation of the diagnosis
* Evaluation of inclusion/non-inclusion criteria;
\-- Registration of the drug (or other) therapy that the study participant receives;
* The presence of bad habits;
* Rating on the YMRS scale;
* Assessment on the MADRS scale;
* Assessment on the Barratt impulsivity scale;
* Score on the Go-no-go task
* Score on the Ballon Analog Risk Task (BART)
* Delivery of the drug
* Functional magnetic resonance imaging (fMRI) (optional)
Visit 2 / Day 14±3
The following procedures will be carried out on Visit 2:
* Registration of the drug (or other) therapy that the study participant receives;
* Assessment of the subject's compliance;
* Correction of the dose of the drug\*;
* Registration of adverse reactions / adverse events;
* Assessment on the Barratt impulsivity scale;
* Score on the Go-no-go task
* Score on the Ballon Analog Risk Task (BART)
* Delivery of the drug
* fMRI (optional)
Visit 3 / Day 42±3 Registration of the drug (or other) therapy that the study participant receives;
* Assessment of the subject's compliance;
* Registration of adverse reactions / adverse events;
* Assessment on the Barratt impulsivity scale;
* Score on the Go-no-go task
* Score on the Ballon Analog Risk Task (BART)
* fMRI (optional)
Concomitant therapy Within the framework of this study, patients can receive any pharmacotherapy therapy, with the exception of quetiapine in higher doses than prescribed by the protocol. At each visit, the doctor should interview the patient about any medications used by the patient during participation in the study. Information about the patient's intake of concomitant medications is entered by the doctor in the IRC.
Functional magnetic resonance imaging (fMRI) As part of this study, an additional fMRI procedure will be performed for a part of patients (10 people) to assess the functional activity of the brain when performing the Go-no-GO test.
Total duration of the study The expected duration of the subjects' participation in the study corresponds to the expected duration of taking the drug and for each participant will be 42 ± 3 days. The inclusion of patients in the study will continue until their total number reaches 30 people.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Quetiapine 25-75 mg
There is one arm in this study. Patients will take quetiapine in dose 25-75 1-3 times a day.
Dose and its frequency can be adjusted by researcher during first 2 weeks (till visit 2), after that patients will take stable dose of quetiapine till week 6 (visit 3).
Quetiapine
25-75 mg per day for 6 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Quetiapine
25-75 mg per day for 6 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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)
3. Age from 18 to 65 years inclusive;
4. The patient's desire and ability to participate in the study and follow the doctor's instructions.
Exclusion Criteria
2. The presence of an actual active phase of bipolar disorder: depression (MADRS score above 22 points) or mania (YMRS score above 20 points).
3. Hypersensitivity to the components of quetiapine in the anamnesis;
4. Current clinically significant and unstable somatic diseases.
5. Participation in other observational programs or clinical trials during the conduct of this study.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kazan State Medical University
OTHER
Federal State Budgetary Institution V.M. Bekhterev National Research Medical Center for Psychiatry and Neurology, Saint-Petersburg, Russia
UNKNOWN
Federal Stare Budgetary Scientific Institution, Mental Health Research Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Margarita Morozova
Head of laboratory of psychopharmacology, PhD,
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Margarita A Morozova, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal Stare Budgetary Scientific Institution, Mental Health Research Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mental health research center
Moscow, , Russia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Margarita A Morozova, PhD
Role: primary
Sergey S Potanin, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SBAD-1
Identifier Type: -
Identifier Source: org_study_id