Back to resultsFlupentixol and Melitracen Tablets in the Treatment of Emotional Disorder
Primary Purpose
Emotional Disorder, Neurologic Disorder
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Flupentixol melitracen tablets
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Disorder
Eligibility Criteria
Inclusion Criteria:
- men and women aged 18-70;
- 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;
- The informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study;
- The subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures.
Exclusion Criteria:
- patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases;
- Patients in critical condition or dying can not participate in this study;
- Pregnant or lactating women;
- Substance abuse patients;
- Allergic to Deanxit;
- Mental disorder; Coma;
- Untreated angle closure glaucoma;
- In the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia;
- Monoamine oxidase inhibitors were used;
- Participated in any other studies involving studies or post marketing drugs within 30 days prior to screening;
- 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;
- Inability and / or unwillingness to understand and / or comply with the protocol.
Sites / Locations
- Peking University Third Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flupentixol melitracen tablets
Arm Description
The patients were treated with Flupentixol melitracen tablets according to their own conditions
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
Status of depression
Status of depression was evaluated by Hamilton Depression Scale(HAMD),ranging from 0-54,the higher score means the worse outcome.
Full Information
NCT ID
NCT04970667
First Posted
June 27, 2021
Last Updated
July 12, 2021
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04970667
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Disorder, Neurologic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flupentixol melitracen tablets
Arm Type
Experimental
Arm Description
The patients were treated with Flupentixol melitracen tablets according to their own conditions
Intervention Type
Drug
Intervention Name(s)
Flupentixol melitracen tablets
Intervention Description
Patients were treated with Flupentixol and melitracen tablets for 12 weeks
Primary Outcome Measure Information:
Title
Effectiveness of Flupentixol and Melitracen Tablets
Description
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%.
Time Frame
The change of frequence of forced crying betwen baseline and twelfth week.
Secondary Outcome Measure Information:
Title
Status of depression
Description
Status of depression was evaluated by Hamilton Depression Scale(HAMD),ranging from 0-54,the higher score means the worse outcome.
Time Frame
At 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
men and women aged 18-70;
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;
The informed consent form signed by the subject indicates that the subject has been informed of all the contents related to the study;
The subjects are willing and able to comply with the study visit schedule, treatment plan, laboratory examination and other study procedures.
Exclusion Criteria:
patients with acute infection, acute trauma, perioperative period and acute attack of chronic diseases;
Patients in critical condition or dying can not participate in this study;
Pregnant or lactating women;
Substance abuse patients;
Allergic to Deanxit;
Mental disorder; Coma;
Untreated angle closure glaucoma;
In the early recovery of myocardial infarction, patients with different degrees of heart block or arrhythmia and coronary artery ischemia;
Monoamine oxidase inhibitors were used;
Participated in any other studies involving studies or post marketing drugs within 30 days prior to screening;
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;
Inability and / or unwillingness to understand and / or comply with the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dongsheng Fan
Organizational Affiliation
Peking University Third Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijin
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder
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