Ketamine-Induced Brain Changes and Their Modulation by Lamotrigine

• Status: Completed
• Trial end date: 2020-12-10
• Target enrollment: 0
• Participant gender: All

Summary

This study is firstly designed to investigate acute and delayed effects of a single dose of ketamine on functional brain changes during emotional and cognitive challenges and at rest. Secondly, it aims to investigate whether functional brain changes after ketamine require increased glutamatergic signaling and will accordingly be modulated after pretreatment with lamotrigine.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Boehringer Ingelheim
• Treatments: Anticonvulsants; Ketamine; Lamotrigine

Criteria

Main Inclusion Criteria:

• From 18 to 45 years of age, inclusive

• Body Mass Index (BMI) between 18.0 and 28.5 kg/m2, inclusive

• Healthy on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead ECG

Main Exclusion Criteria:

• Clinically relevant allergy or drug hypersensitivity

• A history of psychiatric or neurologic disorders

• Alcohol or substance dependence within the last 12 months from screening

• A positive urine drug screen at any visit

• MR exclusion criteria, elevated intracranial pressure or glaucoma

• Hypertonia, cardiac insufficiency, myocardial infarct within last 6 months

• Liver or renal function disorder

• Prescription of psychotropic medication within 28 days prior to screening

• Non-prescription medication, including analgesics and supplements such as vitamins and herbal supplements within 48 hours prior to the baseline visit