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Efficacy and safety study of bupropion in patients with major depressive disorder with reduced positive affect

Efficacy and safety study of bupropion in patients with major depressive disorder with reduced positive affect

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070221
Enrollment
Unknown
Registered
2023-04-06
Start date
2023-04-06
Completion date
Unknown
Last updated
2023-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

Monotherapy therapy group:Bupropion monotherapy
Combined treatment group :Bupropion combined with other antidepressants

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Outpatients or inpatients aged 18-65 years old (including 18 and 65 years old), male or female; 2. Meeting the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for major depressive disorder as assessed by the Chinese version of the Brief International Neuropsychiatric Interview (M.I.N.I.) 7.0.2, either first episode or recurrent, without psychotic symptoms; 3. Baseline Hamilton Depression Scale (HAMD-17) score >= 17; 4. The total score of HAMD-17 low motivation factor (items 1, 7, 8, 13, 14) >= 5; 5. No antidepressant treatment for at least 14 days before enrollment (fluoxetine should be discontinued for at least 28 days for patients treated with fluoxetine before enrollment); 6. I understand and voluntarily participate in this study, and I sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Current or past diagnosis of a major mental disorder other than major depressive disorder according to the DSM-5, such as neurodevelopmental disorder, neurocognitive disorder, schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, and personality disorder; 2. An episode of depression secondary to an organic mental disorder due to a systemic disease or a neurological disease, such as depression due to hypothyroidism; 3. Having a history of alcohol or drug abuse in the previous year; 4. Patients with severe or unstable cardiovascular, respiratory, hepatic, renal, endocrine, hematological or other systemic diseases considered by the investigator to be ineligible for the study; 5. Investigator's assessment of current suicide risk (HAMD-17 item 3) or suicidal behavior/attempt within 6 months before screening; 6. If the patient's physical examination and laboratory examination are abnormal and judged to be clinically significant by the investigator in the baseline period; 7. Received modified electroconvulsive therapy (MECT) 3 months before screening; 8. Stopping psychotropic drugs before screening did not reach 7 half-lives; 9. Allergic constitution (allergic to more than two substances) or allergic to the drug to be used; 10. Positive blood chorionic gonadotropin (HCG)/ urine HCG test in pregnant, lactating women, or women of childbearing age during screening; Or men of reproductive potential or women of reproductive age at the time of the trial were unable to use effective contraception; Or plan to become pregnant within 3 months of the start of the trial; 11. Patients who had participated in other drug clinical trials within 4 weeks before screening; 12. The investigator considered that he was not suitable to participate in the study for other reasons.

Design outcomes

Primary

MeasureTime frame
Low power factor of the Hamilton Depression Inventory;

Secondary

MeasureTime frame
Snaith-Hamilton Pleasure Scale;fatigue severity scale;Sheehan Disability Scale;Arizona Sexual Experience Scale;

Countries

China

Contacts

Public ContactWang Chuanyue

Beijing Anding Hospital, Capital Medical University

wang.cy@163.net+86 13910909974

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026