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| Name | Class |
|---|---|
| Kazan State Medical University | OTHER |
| Federal State Budgetary Institution V.M. Bekhterev National Research Medical Center for Psychiatry and Neurology, Saint-Petersburg, Russia | UNKNOWN |
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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.
The purpose of this study is to study the efficacy and safety of the administration of Quetiapine ® in small doses (25-75 mg / day) to patients diagnosed with bipolar disorder who are in an euthymic state with signs of impaired impulse control.
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:
Visit 3 / Day 42±3 Registration of the drug (or other) therapy that the study participant receives;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine 25-75 mg | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | 25-75 mg per day for 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Statistically significant changes in Barratt Impulsiveness Scale | Statistically significant changes in Barratt Impulsiveness Scale from visit 1 to visit 3. Minimum score for this scale is 55, maximum score is 120, higher scores mean worse outcome. | 6 weeks of treatment |
| Statistically significant changes in total earnings score of Ballon Analog Risk Task (BART) | In Ballon Analog Risk Task (BART) participants should earn as many points as they can during task. Total score is major parameter, measured in points, more points means better outcome. | 6 weeks of treatment |
| Statistically significant changes in dprime parameter in Go-no-Go task | In Go-no-Go task participants should push the button on keyboard whan they see certain pictures and dont push when there see any other pictures. Dprime is major parameter which summarizes number of right and wrong answers, measured in points, more points means better outcome. | 6 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margarita A Morozova, PhD | Contact | +74951090393 | 4100 | margmorozova@gmail.com |
| Sergey S Potanin, PhD | Contact | +74951090393 | 4102 | potanin_ss@mail.ru |
| Name | Affiliation | Role |
|---|---|---|
| Margarita A Morozova, PhD | Federal Stare Budgetary Scientific Institution, Mental Health Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental health research center | Recruiting | Moscow | 115522 | Russia |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 19, 2022 | |
| Reset | Jan 23, 2023 | |
| Release | Mar 24, 2023 | |
| Reset | Jan 3, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 19, 2022 | Jan 23, 2023 | |||
| Mar 24, 2023 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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Open label study
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| Jan 3, 2024 |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |