Patients with depressive episodes of bipolar affective disorder
Conditions
Interventions
Control group:Oral Quetiapine Fumarate Immediate-release Tablets
Study group:Oral administration of Piromilone Hydrochloride Tablets
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Meets the DSM-5 diagnostic criteria for bipolar disorder and is in the stage of depressive episode, with a duration of 2-3 weeks; 2. Age 12-17 years old, gender not limited; 3. Hamilton Depression Rating Scale (HAMD-17) score >= 17 points, item 1 (depressive mood) in HAMD-17 score >= 2 points; 4. The YMRS score on the Yang Mania Scale is <= 12 points; 5. Hamilton Anxiety Scale (HAMA) score<14 points; 6. Female participants need to exclude the possibility of pregnancy; 7. The patient and their legal guardian fully understand the relevant information of the study and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals who meet the DSM-5 diagnosis criteria for psychiatric disorders other than bipolar disorder (schizophrenia, unipolar depression, substance use disorders, etc.) and are deemed unsuitable for clinical trials by the researchers; 2. Having a history of one or more serious suicide attempts within the previous 3 months (based on the researcher's judgment), or answering "yes" to item 4 or 5 of the Colombian Suicide Severity Rating Scale C-SSSRS for "suicidal ideation" during baseline screening; 3. Serious systemic diseases (including but not limited to severe hyperthyroidism, severe hypertriglyceridemia (fasting triglyceride >= 5.6 mmol/L), poorly controlled diabetes, epilepsy, severe arrhythmia, long QT syndrome, paralytic intestinal obstruction, severe pneumonia, autoimmune diseases, etc.), or those who are judged by the researcher to be unsuitable for clinical trials; 4. Individuals who are allergic to research drugs and their excipients; 5. History of poor efficacy or no response to previous treatm; 6. Subjects must stop using antipsychotic and antidepressant medications for at least 5 half-lives before randomization; 7. Individuals who have undergone electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or participated in any other interventional clinical trials within one month prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Scale Score;Cognitive Function ; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing An Ding Hospital, Capital Medical University
Outcome results
None listed