Evaluation of the effectiveness of metformin prophylaxis in preventing risperidone-induced hyperprolactinemia in children and adolescents
- Conditions
- Hyperprolactinemia caused by risperidone.HyperprolactinemiaE22.1
- Registration Number
- IRCT20200304046698N2
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method