Antipsychotic drug-induced hyperprolactinemia
Conditions
Interventions
Experimental group:Administer 240mg of HMI-115 by subcutaneous injection
Control group:Administering a placebo subcutaneous injection
Sponsors
Beijing An Ding Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Women aged 18-40 (including both 18 and 40 years old); 2.Serum prolactin level higher than 87.6ng/mL; 3.At least one obvious symptom of hyperprolactinemia appears, including infrequent menstruation (1 or 2 menstrual periods in the past 3 months or<7 menstrual periods in the past 12 months, or menstrual cycle length of 36-89 days), amenorrhea (cessation of menstruation for 3 months in those with normal menstrual frequency or 6 months in those with previous infrequent menstruation), and galactorrhea. 4.Meets the diagnostic criteria for schizophrenia according to the international classification standard ICD-10 F20. 5.The patient is treated with antipsychotic drugs (including risperidone, paliperidone, amisulpride, etc.), and their mental state is stable. The patient has been receiving stable treatment for at least 2 months, and their positive and negative symptom scale (PANSS) scores are less than 70. The types of antipsychotic drugs remain unchanged
Exclusion criteria
Exclusion criteria: 1.Any other major mental illness; 2.Diseases of hypothalamus and pituitary gland; 3.Galactorrhea caused by breast lesions; 4.Menstrual thinning or amenorrhea caused by uterine or ovarian lesions; 5.I am currently taking medication that affects my menstrual cycle, such as metformin, short acting contraceptives, Wujibaifeng pills, valproic acid, etc; 6.Participated in other clinical trials within the first 3 months of screening; 7.Female subjects diagnosed with perimenopause; 8.Pregnant, lactating women or women with pregnancy plans during the participation of this trial; 9.Severe concurrent physical illnesses, organic brain disorders, history of substance and alcohol abuse, and intellectual disability; 10.Currently taking medication that affects prolactin, such as aripiprazole
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Menstrual improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Scale (HAMA) score;Calgary Schizophrenia Depression Scale (CDSS) score;Change in Columbia-Suicide Severity Rating Scale (C-SSRS) score;Incidence of Adverse Events;Change in Extrapyramidal Symptoms Scores;Quality of Life Rating Scale (SF-12) Score;Change in Arizona Sexual Experience Scale (ASEX) total score;Galactorrhea improvement rate; | — |
Countries
China
Contacts
Public ContactGang Wang
Beijing Anding Hospital Affiliated to Capital Medical University
Outcome results
None listed