Bipolar Disorder
Conditions
Interventions
Phase One - Group 1 (Mood Stabilizer Combined with Bupropion) - 8 Weeks of Acute Phase Treatment.:Mood Stabilizers + Bupropion
Phase One - Group 2 (Mood Stabilizer) - 8 Weeks of Acute Phase Treatment.:Mood stabilizer treatment
Phase Two - Clinical Remission Group - Follow-up Observation for 1 Year in the Maintenance Phase:Treatment with mood stabilizers combined with bupropion hydrochloride or monotherapy with mood stabiliz
Phase Two - Clinical Non-remission Group - Follow-up Observation for 1 Year in the Maintenance Phase:Receive open-label treatment with no restrictions on the type or dosage of medication.
Sponsors
Beijing Anding Hospital affiliated to Capital Medical University.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Outpatients or inpatients aged 18-65 years (including both 18 and 65 years old), with no gender restrictions (2) Meet the DSM-5 diagnosis of "Bipolar affective disorder, currently in a depressive episode" through the M.I.N.I. 7.0.2 structured interview (3) Have not regularly taken antidepressants, antipsychotics, or mood stabilizers for at least 14 days prior to enrollment (4) Able to understand and complete the assessment content (5) Have personally signed the informed consent form
Exclusion criteria
Exclusion criteria: (1) Currently or previously diagnosed with other major mental disorders in accordance with DSM-5, excluding bipolar affective disorder, such as neurodevelopmental disorders, neurocognitive disorders, schizophrenia and other psychotic disorders, alcohol (or drug) dependence, and personality disorders (2) The current depressive episode is accompanied by psychotic symptoms (3) History of epilepsy or other severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, hematologic, or other systemic diseases, which the researcher deems unsuitable for inclusion in this study (4) Allergic to bupropion (5) Patients currently at severe risk of suicide, with a score =3 on item 3 of the HAMD-17 (6) Abnormalities in physical examination or laboratory tests during the screening or baseline period that the researcher judges to have significant clinical implications (7) Received MECT within the 3 months prior to screening (8) Discontinuation of psychotropic medication has not reached 7 half-lives before screening (9) Patients who are pregnant or breastfeeding (10) For other reasons deemed unsuitable by the researcher to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of clinical remission rates between the two groups of subjects at the end of 8 weeks of treatment: Clinical remission is defined as a HAMD score of =7 and a YMRS score of =5 at the end of 8 weeks.;Recurrence rate and time to recurrence: The proportion of individuals in both groups who experienced a recurrence (as assessed by the investigator according to DSM-IV criteria for a depressive episode) and the difference in time to recurrence during the 52-week maintenance follow-up period.;Treatment adherence: Assessed using the PAQ, patients are considered non-adherent if they do not take their prescribed medication =70% of the time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization: During the 52-week maintenance phase follow-up, the proportion of participants in both groups who were hospitalized due to psychiatric episodes or affective events.;Switching phases: During the 52-week maintenance period follow-up, the proportion of participants in both groups who met the DSM-5 criteria for manic, hypomanic, or mixed episodes, with a total score of =10 on the ASRM scale.;High risk of suicide: The proportion of individuals in both groups who exhibited suicidal behavior or serious suicide attempts during the 52-week maintenance follow-up period;The change values from baseline for HAMD-17HAMAYMRSIDS-30,QIDS-SR16ASRM SHAPSGAD-7PDQPRISE and PAQ scales at each visit point in both groups; | — |
Countries
china
Contacts
Public Contactjingjingzhou
Beijing Anding Hospital affiliated to Capital Medical University.
Outcome results
None listed