Validation of concomitant medications affecting lamotrigine blood levels

JRCT ID: jRCT1061220093

Registered date:01/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bipolar disorder, epilepsy
• Date of first enrollment: 01/02/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Patients with psychiatric disorders who have been taking lamotrigine (Lamictal) for at least 2 weeks and have reached steady state will be included in the study and will be treated with the same pharmacotherapy as in usual practice. No changes in LTG dose or concomitant medications will be made for this study. In addition to usual medical care, approximately 5 ml of blood will be drawn for research purposes to measure LTG blood levels.Analyze whether LTG blood levels change with or without concomitant use of drugs that exhibit UGT inhibitory effects (flunitrazepam, nitrazepam).

Outcome(s)

• Primary Outcome: Based on the data obtained, the population pharmacokinetics of lamotrigine in epilepsy patients will be used to estimate trough values, AUC, etc., to evaluate the effect on LTG concentrations in concomitant drugs.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. cases in which LTG was prescribed for the treatment of psychiatric disorders in our psychiatry department
2. cases in which the patient (or a substitute) has given written consent

Exclude criteria

1. patients under 18 years of age
2. patients for whom it is impossible to measure LTG blood concentration due to the unavailability of samples necessary for the measurement
3. patients whose consent could not be obtained
4. other patients deemed ineligible by the physician in charge

Related Information

• Primary Sponsor: Ishizawa Keisuke