Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder

Neurologic Disorder Clinical Trial

Official title:

Clinical Study of Flupentixol and Melitracen Tablets in the Treatment of Non Random Emotional Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04970667
• Other study ID #: M2017013
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Emotional Disorder
• Mood Disorders
• Nervous System Diseases
• Neurologic Disorder

Intervention

Drug:
• Flupentixol melitracen tablets
Patients were treated with Flupentixol and melitracen tablets for 12 weeks

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijin

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Flupentixol and Melitracen Tablets	Indicators of drug effectiveness: the difference between the number of crying episodes after 12 weeks of medication minus the number of crying episodes at baseline divided by the number of crying episodes at baseline. Complete remission was achieved when the attack disappeared, effective when the attack frequency decreased more than 50%, invalid when the attack frequency decreased less than or equal to 50%.	The change of frequence of forced crying betwen baseline and twelfth week.
Secondary	Status of depression	Status of depression was evaluated by Hamilton Depression Scale(HAMD),ranging from 0-54,the higher score means the worse outcome.	At 12th week