Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder

Last updated: July 12, 2021
Sponsor: Peking University Third Hospital
Overall Status: Completed

Phase

4

Condition

Kleptomania

Affective Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT04970667
M2017013
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 randomemotional expression disorder;
  3. The informed consent form signed by the subject indicates that the subject has beeninformed of all the contents related to the study;
  4. The subjects are willing and able to comply with the study visit schedule, treatmentplan, laboratory examination and other study procedures.

Exclusion

Exclusion Criteria:

  1. patients with acute infection, acute trauma, perioperative period and acute attack ofchronic 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 ofheart 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 30days prior to screening;
  11. According to the judgment of the researcher, there are other serious acute or chronicmedical or psychiatric conditions or laboratory abnormalities that may increase therisks associated with participating in the trial or using the research products, ormay affect the interpretation of the research results, which may make the subjectsunsuitable for participating in the trial;
  12. Inability and / or unwillingness to understand and / or comply with the protocol.

Study Design

Total Participants: 100
Study Start date:
January 01, 2018
Estimated Completion Date:
April 30, 2020

Study 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.

Connect with a study center

  • Peking University Third Hospital

    Beijin,
    China

    Site Not Available

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