Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder

• ClinicalTrials.gov Identifier: NCT04970667
• Recruitment Status: Completed
• First Posted: July 21, 2021
• Last Update Posted: July 21, 2021
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Peking University Third Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Emotional Disorder; Neurologic Disorder	Drug: Flupentixol melitracen tablets	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Flupentixol and Melitracen Tablets in the Treatment of Non Random Emotional Disorder
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: January 31, 2020
• Actual Study Completion Date: April 30, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Effectiveness of Flupentixol and Melitracen Tablets [ Time Frame: The change of frequence of forced crying betwen baseline and twelfth week. ]
   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%.

Secondary Outcome Measures :

1. Status of depression [ Time Frame: At 12th week ]
   Status of depression was evaluated by Hamilton Depression Scale(HAMD),ranging from 0-54,the higher score means the worse outcome.

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China

Peking University Third Hospital

Beijin, China

Sponsors and Collaborators

Peking University Third Hospital

Investigators

• Principal Investigator: Dongsheng Fan; Peking University Third Hospital

More Information

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04970667
• Other Study ID Numbers: M2017013
• First Posted: July 21, 2021
• Last Update Posted: July 21, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Nervous System Diseases; Mood Disorders; Mental Disorders; Flupenthixol; Flupenthixol decanoate; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action