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Adjunctive aripiprazole treatment for risperidone-induced hyperprolactinemia: an 8-week randomized, open-label, comparative clinical trial

Adjunctive aripiprazole treatment for risperidone-induced hyperprolactinemia: an 8-week randomized, open-label, comparative clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15006278
Enrollment
Unknown
Registered
2015-04-22
Start date
2012-09-30
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Schizophrenia

Interventions

control group :no additional treatment
aripiprazole group :adjunctive treatment with aripiprazole 10mg/day

Sponsors

The Second Affiliated Hospital/ Xinxiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-45 years; 2. diagnosis of schizophrenia or schizoaffective disorder; 3. stable psychiatric condition; 4. stable on risperidone (4-6 mg/day) for at least 8 weeks; 5. elevated serum prolactin level (>324mIU/L in males and >496mIU/L in females) associated with risperidone treatment; 6. willingness (female subjects of childbearing potential) to practice appropriate birth control methods during the study.

Exclusion criteria

Exclusion criteria: 1. inability to provide informed consent; 2. current substance abuse; 3. other significant illnesses including severe cardiovascular, hepatic, or renal disease; 4. history of immunosuppression; 5. current or recent radiation or chemotherapy treatment for cancer; 6. pregnancy or breastfeeding; 7. a history of serious adverse reactions to aripiprazole or a history of tardive dyskinesia or neuroleptic malignant syndrome; 8. other conditions (e.g., thyroid or gynecological diseases) that could affect serum prolactin levels.

Design outcomes

Primary

MeasureTime frame
prolactin;total cholesterol;low density lipoproteins;high density lipoproteins;triglycerides;glucose;body mass index;

Countries

China

Contacts

Public ContactLv Luxian
13460480548@163.com+86 13460480548

Outcome results

None listed

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