bipolar disorder
Conditions
Interventions
Experimental group:treatment with lurasidone
Control group:treatment with quetiapine
Sponsors
Beijing AnDing Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
14 Years to 24 Years
Inclusion criteria
Inclusion criteria: 1. After the patient has fully explained and understood the purpose, content, expected treatment and pharmacological effects and risks of the research, the patient and the legal representative voluntarily signed a written informed consent; 2. Outpatients aged 14 to 24 years; 3. Patients who are in line with bipolar disorder and currently have a depressive episode (diagnosed according to DSM-5 criteria); 4. At the time of enrollment, the current depressive episode >= 2 weeks; 5. Patients with MADRS total score >=22 and YMRS total score <=12 at screening and baseline; 6. For women of childbearing potential, patients with negative urine pregnancy tests at screening.
Exclusion criteria
Exclusion criteria: 1. Patients with a lifetime history of severe mental disorders or with symptoms consistent with severe mental disorders (except for bipolar disorder as defined by DSM-5); 2. Patients with MADRS item 10 (suicidal ideation) score >=4 at screening or baseline; 3. Patients who are considered by the investigator to be suicidal and at immediate risk of harming themselves or others, and those who answered "Yes" to item 4 or 5 of the C-SSRS at screening or baseline; 4. Patients using monoamine oxidase inhibitor (MAOI), fluoxetine, clozapine, any long-acting injection (sustained-release injection) antipsychotics within 21 days before screening; 5. Patients with clinically significant comorbidities in the past or at present, and the researchers believe that they are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Montgomery Asperger Depression Scale score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical general impression - bipolar disorder version severity scale score;sheehan disability scale score;Hamilton Anxiety Scale score;Young's Mania Rating Scale;Effective rate;complete remission rate;Abnormal Involuntary Movement Scale score;Simpson Angus scale score;Barnes Akathisia Rating Scale score; | — |
Countries
Chia
Contacts
Public ContactWang Wei
Beijing AnDing Hospital, Capital Medical University
Outcome results
None listed