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A randomized, controlled study of the effects of Sweet Dream Oral Liquid on serum prolactin, sexual function, extrapyramidal symptoms (EPS) and cognitive function in male schizophrenic patients on long-term atypical antipsychotic medication

A randomized, controlled study of the effects of Sweet Dream Oral Liquid on serum prolactin, sexual function, extrapyramidal symptoms (EPS) and cognitive function in male schizophrenic patients on long-term atypical antipsychotic medication

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063269
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Experimental group:Regular treatment, additional use Sweet Dream Oral Liquid 10mL po bid
Control group:Regular treatment

Sponsors

Wuhan Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for schizophrenia in the Chinese Classification and Diagnostic Standard of Mental Disorders, 3rd Edition (Classification of Mental Disorders); 2. A total score of >= 60 on the Positive and Negative Symptom Scale (PANSS); 3. Inpatient aged 18-60 years, male; 4. Treatment with maintenance doses of atypical antipsychotics for >= 12 weeks and no endocrine-affecting drugs, such as prednisone; 5. Subjects need to have the ability to understand and communicate effectively with the investigator to complete study-related assessment components; 6. The patient's family has signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those with a family history of obesity; 2. Renal failure; abnormal thyroid function; ovarian lesions; pituitary tumours; 3. Persons with a history of psychoactive drug dependence; 4. Persons with a positive urine drug screen and alcohol or drug abuse/dependence within the past year; 5. Patients who have had an ineffective treatment with Sweet Dream Oral Solution within 2 months prior to assessment; 6. Patients with psychiatric disorders due to organic somatic diseases; 7. Patients who are uncooperative, unable to communicate or deemed unsuitable by the investigator to participate in the study.

Design outcomes

Primary

MeasureTime frame
Prolactin;Testosterone;Complete Blood Count;

Secondary

MeasureTime frame
Brain-derived neurotrophic factor;Interleukin-6;C-reactive protein;

Countries

China

Contacts

Public ContactMaosheng Fang

Wuhan Mental Health Center

shelyue@163.com+86 27 82281670

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026