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Evaluation of the effectiveness of metformin prophylaxis in preventing risperidone-induced hyperprolactinemia in children and adolescents

Evaluation of the effectiveness of metformin prophylaxis in preventing risperidone-induced hyperprolactinemia in children and adolescents

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200304046698N2
Enrollment
40
Registered
2024-07-03
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Hyperprolactinemia caused by risperidone. Hyperprolactinemia

Interventions

Intervention 1: Intervention group:The group treated with immediate-release oral metformin 500 mg, prepared by the pharmaceutical group, with a starting dose of 1/2 tablet twice a day, which was incre

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patient and parent consent to participate in the study Age 10 to 18 years Psychiatric necessity for taking risperidone Normal prolactin at the beginning of the study

Exclusion criteria

Exclusion criteria: Allergy to risperidone or metformin Need to change risperidone or add a second drug due to lack of control of psychiatric symptoms Intolerable or severe side effects with risperidone and metformin Occurrence of short-term physical symptoms of hyperprolactinemia Previous or current history of neurological disease (current seizure disorders, history of head trauma, migraine) Previous or current history of systemic disease (blood, endocrine, liver, thyroid, kidney, metabolic disease) Smoking and any type of drug Taking medication that interacts with metformin Positive pregnancy test in teenage girls Taking any type of drug affecting the plasma level of prolactin (including other antipsychotics, antidepressants, and stimulants)

Design outcomes

Primary

MeasureTime frame
Prolactin blood level. Timepoint: before the start of the intervention and 6 weeks after the start of the drug. Method of measurement: Blood prolactin level check.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMina Ayatollahi Mehrjardi

Shahid Beheshti University of Medical Sciences

ehlib@sbmu.ac.ir+98 21 7343 0000

Outcome results

None listed

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