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Effect of different dosage of aripiprazole on preventing risperidone-induced hyperprolactinemia: a 8-week, multicenter, randomized, open-label, controlled trial

Effect of different dosage of aripiprazole on preventing risperidone-induced hyperprolactinemia: a multicenter, randomized, open-label, controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027504
Enrollment
Unknown
Registered
2019-11-17
Start date
2017-03-01
Completion date
Unknown
Last updated
2019-11-18

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

Conditions

Schizophrenia

Interventions

Group A:Patients treated with risperidone alone for 8 weeks
Group B:Patients treated with risperidone and 5 mg/day aripiprazole for 8 weeks
Group C:Patients treated with risperidone and 10 mg/day aripiprazole for 8 weeks

Sponsors

Shandong Mental Health Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: (1) 18-45 years of age; (2) Diagnosed with schizophrenia; (3) Positive and Negative Rating Scale (PANSS) total score>=60; (4) First episode or no any treatment was used within 3 months.

Exclusion criteria

Exclusion criteria: (1) With other psychotic disorder; (2) Other serious physical illness including severe cardiovascular, hepatic, or renal disease and so on; (3) Diagnosed with pituitary tumor, hypothalamic disease, thyroid disease, primary or secondary amenorrhea; (4) Elevated serum prolactin levels at baseline (>24ng/ml in female and >20ng/ml in male); (5) Taking medicine which can influence prolactin levels like estrogen; (6) Current substance abuse (including alcohol consumption).

Design outcomes

Primary

MeasureTime frame
Serum prolactin levels;

Secondary

MeasureTime frame
The Positive and Negative Syndrome Scale (PANSS);CGI;

Countries

China

Contacts

Public ContactGuanglei XUN

Shandong Mental Health Center

xungl@163.com+86 15069053599

Outcome results

None listed

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