NCT04205890

Intravenous Ketamine Effects on Functional Neuroanatomy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Neurological Associates of West Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate the neuroanatomical effects of ketamine treatment on patients with treatment-resistant depression. The investigators will compare the neuroimaging of patients several days before and after injection in order to assess the more durable changes induced by ketamine. In addition, changes in perfusion will be analyzed, in addition to changes in neurovascular coupling, and functional connectivity that are correlated with psychiatric measures.

Detailed description

The present study is designed as a prospective data analysis of patient response to the use of ketamine to treat treatment-resistant depression. For Phase I trail, 10 patients of any gender with an age range of 18 to 70 who have undergone the outlined procedure will be recruited for inclusion. Patients will be examined by the principle investigator. All patients must be diagnosed with persistent treatment-resistant depression and prescribed ketamine. Patients will be accepted regardless of if the depression coincided with anxiety and/or pain. Patient status will be assessed using the Beck Depression Inventory, Beck Anxiety Inventory, and Brief Pain Inventory. Patients must have a Beck Depression Inventory score of 10 or above. These scores will be used as baseline data. Patients will be offered the option of participating in the study and provided informed consent for neuroimaging before and after the ketamine treatment. A week before the scheduled ketamine treatment, the patients will have fMRI scans, including structural T1, Arterial Spin Labeling, and Resting BOLD. The scans take around 30 minutes at no charge to the patients. The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosages varies between 75mg - 1000mg depending on every individual's unique treatment plan. The same scans will be taken two days after treatment.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Ketamine	The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosage varies between 75mg - 1000mg depending on every individual's unique treatment plan.

Timeline

• Start date: 2020-05-02
• Primary completion: 2020-05-28
• Completion: 2020-05-28
• First posted: 2019-12-20
• Last updated: 2020-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study