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A real-world study of the efficacy and safety of agomelatine in combination with second-generation antipsychotics for the treatment of negative symptoms in patients with schizophrenia

A real-world study of the efficacy and safety of agomelatine in combination with second-generation antipsychotics for the treatment of negative symptoms in patients with schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090044
Enrollment
Unknown
Registered
2024-09-23
Start date
2022-11-15
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

schizofrenia

Interventions

Intervention group:Agomelatine in combination with second-generation antipsychotics
control group:Second-generation antipsychotics alone

Sponsors

Jingzhou Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 18~65 years old, right-handed; (2) The main objective of this study was to explore the grouping treatment status of patients with negative symptoms of schizophrenia, so the following criteria were set when the samples were included: 7 points< 28 points on the PANSS positive symptoms subscale score = (all 7 items scored =4 points, i.e., none of them exceeded moderate); The PANSS Negative Symptom Scale has a score of =24 and at least 2 of the 3 core symptoms (emotional dullness, passivity/apathy, social withdrawal, and lack of spontaneity and fluency in conversation) = 4 or more; (3) The patient is aware of the study and signs the informed consent form,

Exclusion criteria

Exclusion criteria: (1) Patients with cerebral organic mental disorders or other severe mental disorders at the same time, or with severe positive symptoms or depressive symptoms (such as patients with strong suicidal ideation and recent history of suicide attempts); (2) Accompanied by mental retardation or other serious underlying diseases or physical diseases (such as auditory, visual impairments) that may affect the evaluation; (3) History of drug abuse or drug or alcohol dependence within the past 1 year; (4) Positive antibodies to hepatitis B virus, hepatitis C virus, anti-human immunodeficiency virus or elevated serum aminotransferases greater than or equal to the upper limit of normal; (5) the need for treatment with antidepressants other than agomelatine; (6) Those who have received MECT and rTMS treatment in the past month; (7) Allergy to agomelatine and its excipients or pregnant women, lactating women and women of childbearing age who do not take contraceptive measures. (8) Since low-dose amisulpride is widely accepted as one of the effective methods to improve negative symptoms of schizophrenia, we excluded this subset of patients who received amisulpride at the time of enrollment.

Design outcomes

Primary

MeasureTime frame
Scores on the PANSS scale;Scores on the SANS scale;

Secondary

MeasureTime frame
Scores on the CGI scale;

Countries

China

Contacts

Public ContactZhang Xinfeng; Chen Zuowei

Jingzhou Mental Health Center

49637569@qq.com+86 138 7229 3762

Outcome results

None listed

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