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Metabolic effects of adding Topiramate on Aripiprazole in bipolar patients under age 18

Randomized controlled trial metabolic effects of adding Topiramate on Aripiprazole in bipolar patients under age 18

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200606047668N1
Enrollment
38
Registered
2020-06-20
Start date
2020-04-21
Completion date
Unknown
Last updated
2020-07-13

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

Conditions

Condition 1: Bipolar disorder. Condition 2: Metabolic syndrome. Bipolar affective disorder Nutritional and metabolic disorders in diseases classified elsewhere

Interventions

Intervention 1: Intervention group: Topiramate tablet (TOPIRAMATE-ARYA 25MG TAB) with dose 25-100mg daily, once daily orally for 3 months. Intervention 2: Control group: placebo tablet(School of Pharm

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Consent to participate in the study by completing the informed consent form by patient and family. Lack of any chronic physical illness. Negative history of recieving any antypsychotic drug or mood stabilizers or drugs that could change appetite during recent 3 month before study Lack of history of allergic reaction to topiramate Lack of history of renal insufficiency or renal stone Age between 6-18 years

Exclusion criteria

Exclusion criteria: patient or family unwillingness to stay in study Need to ECT treatment during study Any unexpected new physical illness that could change medical care of patient

Design outcomes

Primary

MeasureTime frame
Bipolar disorder. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Young mania rating scale.;Fasting blood glucose. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Triglyceride. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Glycated hemoglobin. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Cholestrol. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Low density lipoprotein. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;High density lipoprotein. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Fasting insulin. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit.;Blood pressure. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: sphygmomonometer.;Waist circumference. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard meter.;Weight. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard scale.;Height. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard meter.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMostafa Haghshenas

Esfahan University of Medical Sciences

Tamasha_jums@yahoo.com+98 31 4572 2109

Outcome results

None listed

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