Metformin for control of weight gain related to sodium valproate administration in adults

Effectiveness of Metformin in the control of weight gain related to sodium valproate administration in adults

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017071322991N8

Enrollment

Registered

2017-08-16

Start date

2017-06-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Association of metformin and control of weight gain related to sodium valproate administration in adults. Unspecified mental disorder

Interventions

Intervention 1: Intervention group 1: 500 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks. Intervention 2: Intervention group 2: 500-10

Treatment - Drugs

Placebo

Intervention group 1: 500 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks

Intervention group 2: 500-1000 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks

Intervention group 3: 1000-2000 milligram metformin (manufactured in ARYA Company) in a day in addition to nutrition education for twelve weeks

Control group: placebo in addition to nutrition education for twelve weeks

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age 18 to 65 years; under medication with sodium valproate for at least one month; self-reported weight gain more than three kilogram after sodium valproate administration; filling and assignment the informed consent form Exclusion criteria: diabetes in the patient; endocrine disorder in which the patient is treated with steroids; administration other psychotropic drugs except sodium valproate; suspect to polycystic ovarian disease in the patient; mental retardation or other severe physical or mental disorders which inhibit the cooperation of the patient in the research; pregnancy and breast-feeding; impairment of renal or hepatic function (creatinine or liver enzymes more than 150 percent higher than normal value); alcohol, narcotic and psychotropic drugs consumption

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Weight of the patient. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Digital scale.;Body Mass Index. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Weight (kilogram) divided by squared height (meter).	—

Secondary

Measure	Time frame
Drug side-effects. Timepoint: 4th, 8th and 12th weeks after intervention. Method of measurement: Patient visit.;Quality of life. Timepoint: 12 weeks after intervention. Method of measurement: SF-36 quality of life questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSussan Moudi

Babol University of Medical Sciences

sussan.mouodi@gmail.com+98 11 3219 0624

Outcome results

None listed

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