Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder

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

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

Study Overview

• Status: Completed
• Conditions: Emotional Disorder; Neurologic Disorder
• Intervention / Treatment: Drug: Flupentixol melitracen tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijin, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flupentixol melitracen tablets; The patients were treated with Flupentixol melitracen tablets according to their own conditions	Drug: Flupentixol melitracen tablets; Patients were treated with Flupentixol and melitracen tablets for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 12, 2021
• First Posted (Actual): July 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Nervous System Diseases; Mood Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Flupenthixol; Flupenthixol decanoate
• Other Study ID Numbers: M2017013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No