Clinical trial NCT04970667: Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder
Official title: Clinical Study of Flupentixol and Melitracen Tablets in the Treatment of Non Random Emotional Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Emotional Disorder
Neurologic Disorder
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders

Detailed description: Involuntary emotional expression disorder (ieed) is a kind of disorder of emotion control. Its main clinical feature is frequent short and violent uncontrollable crying and (or) laughing, which is different from mood disorder and self emotional expression.

The mixture of Flupentixol and melitracen is used for antidepressant. Melitracen is a tricyclic antidepressant, while Flupentixol is a neurodepressant in structure, but its dose in Deanxit has antidepressant properties.

The active components of Deanxit are Flupentixol dihydrochloride (Flupentixol) and melitracen (melitracen). Flupentixol is a thiazolyl (thioanthracene) antipsychotic, and melitracen is a tricyclic antidepressant. Low dose Flupentixol (0.5mg-3mg) has antidepressant and antianxiety effects, while melitracen has antidepressant effect. The mixture of the two components is used to treat mild to moderate mental disorders.

The purpose of this study was to evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders.

Eligibility criteria: Inclusion Criteria:

1. men and women aged 18-70;
2. Patients with nervous system diseases (such as stroke, amyotrophic lateral sclerosis, brain trauma, multiple sclerosis, Alzheimer's disease, etc.) accompanied by non random emotional expression disorder;
3. The informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study;
4. The subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures.

Exclusion Criteria:

1. patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases;
2. Patients in critical condition or dying can not participate in this study;
3. Pregnant or lactating women;
4. Substance abuse patients;
5. Allergic to Deanxit;
6. Mental disorder; Coma;
7. Untreated angle closure glaucoma;
8. In the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia;
9. Monoamine oxidase inhibitors were used;
10. Participated in any other studies involving studies or post marketing drugs within 30 days prior to screening;
11. According to the judgment of the researcher, there are other serious acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risks associated with participating in the trial or using the research products, or may affect the interpretation of the research results, which may make the subjects unsuitable for participating in the trial;
12. Inability and / or unwillingness to understand and / or comply with the protocol.

Primary outcomes:
measure: Effectiveness of Flupentixol and Melitracen Tablets
timeFrame: The change of frequence of forced crying betwen baseline and twelfth week.
Secondary outcomes:
measure: Status of depression
timeFrame: At 12th week
Other outcomes:
Locations:
city: Beijin
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Dongsheng Fan
role: PRINCIPAL_INVESTIGATOR
References: