Peking University Third Hospital
Beijin, China
NCT Number: NCT04970667
To evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of different types of non random emotional disorders
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Beijin, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients were treated with Flupentixol and melitracen tablets for 12 weeks
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%.
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.
Peking University Third Hospital
Other
Clinical Study of Flupentixol and Melitracen Tablets in the Treatment of Non Random Emotional Disorder
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