Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms

Open-label study on the efficacy of lamotrigine in patients with brain tumor, stroke or head injury, and comorbid depressive symptoms - Efficacy of lamotrigine in neurosurgical patients with depressive symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009463

Enrollment

Registered

2012-12-03

Start date

2013-01-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Depressive symptoms in patients with brain tumor, stroke, or head injuries, and comorbid epilepsy

Interventions

5 months treatment Patients taking an enzyme-inhibiting antiepileptic drug (AED) receive lamotrigine (LTG) 100 mg per day, and those taking an enzyme-inducing AED receive LTG 200 mg per day.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Included in this study are men and women aged 20 years and older who suffered from brain tumor, stroke, or head injuries and comorbid epilepsy, and who exhibit low to moderate depressive symptoms and are treated with antiepileptic drug. Each patient completes Hospital Anxiety and Depression Scale to verify the presence of mild depressive symptoms.

Exclusion criteria

Exclusion criteria: 1.abnormal liver function 2.history of allergy to other antiepileptic drugs 3.currently pregnant 4.within two weeks after the patients suffered from head injury or stroke 5.within two weeks after brain surgery 6.the life expectancy is less than six months 7.concent of patients can not be obtained because of disturbance of consciousness or cognitive dysfunction 8.patients demonstrate bad compliance

Design outcomes

Primary

Measure	Time frame
Hospital Anxiety and Depression Scale (HADS)	—

Secondary

Measure	Time frame
50% responder rate	—

Countries

Japan

Contacts

Public ContactNaoki Nitta

Shiga University of Medical Science Department of Neurosurgery

nnitta@belle.shiga-med.ac.jp0775482257

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026