A Study on the Efficacy of Agomelatine Combined With Antipsychotics to Treat Negative Symptoms in Schizophrenia

NCT05646264 | Unknown Phase 4

• 1 other identifier: AMN202103
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, multicenter, controlled, real world study. Patients will be randomly enrolled into the test group and the control group at a ratio of 1:1 during the screening period. The test group will choose to add Agomepratin on the basis of a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc., see Annex A), and the control group will either use a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc.) for 24 consecutive weeks, To explore the efficacy and safety of the second generation antipsychotic drugs combined with agomeratine regimen in the real world for negative symptoms of schizophrenic patients. Group sequential design is used as the method of interim analysis in the research process. If the research purpose is reached in advance, the research can be terminated. The study followed GRACE standards.

Conditions

Schizophrenia; Negative Symptoms in Schizophrenia

Outcome Measures

Primary Outcomes (1)

• PANSS

  Reduction rate of total score of PANSS negative scale ≥ 20%

  24WEEKS

Secondary Outcomes (3)

• SANS

  24WEEKS

• GAF

  24WEEKS

• CDSS

  24WEEKS

Other Outcomes (1)

• Health Economics Indicators

  24weeks

Study Arms (2)

Monotherapy group

NO INTERVENTION

Single use of second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.)

Joint group

EXPERIMENTAL

second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.) Add Agomelatine

Drug: Agomelatine

Interventions

Agomelatine DRUG

Agomepratine is added to a second-generation antipsychotic drug (olanzapine, aripiprazole, risperidone, etc.)

Joint group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 18-65;
• Conform to the diagnostic criteria of schizophrenia in the International Statistical Classification of Diseases and Related Health Problems (ICD-10);
• \< PANSS positive symptom subscale score ≤ 28 (7 items score ≤ 4, that is, no more than moderate); PANSS negative symptom subscale score ≥ 24 and at least 2 of 3 core symptoms (emotional dullness, passive/indifferent social withdrawal and lack of spontaneity and fluency in conversation) ≥ 4 points;
• Calgary Schizophrenia Depression Scale (CDSS) score ≤ 18 (score of 9 items ≤ 2, that is, no more than moderate);
• According to the judgment of the researcher, the second-generation antipsychotic drugs (including olanzapine, risperidone, aripiprazole, etc.) can be used alone or added with agomeratine on the basis of them;
• To voluntarily participate in this study, you need to sign an informed consent form with the legal guardian at the same time.

You may not qualify if:

• Exclude patients who meet any of the following criteria:
• Combined with brain organic mental disorder;
• Have a history of drug abuse or drug or alcohol dependence in the past 1 year;
• Suffering from serious basic diseases or physical diseases or diseases that may affect the assessment (such as hearing and vision disorders);
• Suffering from other serious mental disorders at the same time;
• Serious suicide attempt;
• Hepatitis B virus (HBV) surface antigen positive, hepatitis C virus (HCV) antibody positive, anti human immunodeficiency virus (HIV) antibody positive or serum transaminase increased ≥ the upper limit of normal value;
• With mental retardation;
• Allergies to Agomelatine or its excipients;
• Pregnant women, lactating women and women of childbearing age did not take contraceptive measures;
• Currently participating in clinical research of other drugs or medical devices;
• Other antidepressants (including but not limited to SSRI and SNRI drugs) other than agomeratine should be used in combination;
• Accompanied by severe positive symptoms or depressive symptoms;
• The researcher thinks it is not suitable to be included.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead
• Tianjin Anding Hospital: collaborator

Study Sites (1)

Shanghai Mental Health Center

Shanghai, China

RECRUITING

Related Publications (2)

• Banasr M, Soumier A, Hery M, Mocaer E, Daszuta A. Agomelatine, a new antidepressant, induces regional changes in hippocampal neurogenesis. Biol Psychiatry. 2006 Jun 1;59(11):1087-96. doi: 10.1016/j.biopsych.2005.11.025. Epub 2006 Feb 24.

  PMID: 16499883 RESULT

• Englisch S, Jung HS, Lewien A, Becker A, Nowak U, Braun H, Thiem J, Eisenacher S, Meyer-Lindenberg A, Zink M. Agomelatine for the Treatment of Major Depressive Episodes in Schizophrenia-Spectrum Disorders: An Open-Prospective Proof-of-Concept Study. J Clin Psychopharmacol. 2016 Dec;36(6):597-607. doi: 10.1097/JCP.0000000000000587.

  PMID: 27805978 RESULT

MeSH Terms

Conditions

Schizophrenia

Interventions

agomelatine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• yizhenghui1971@163.com Yi, M.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenghui Yi, M.D

CONTACT

18017311007; yizhenghui1971@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)