Deep Brain Stimulation of the Ventral Hippocampus in Treatment-resistant Schizophrenia: Exploring the Glutamatergic/GABAergic Mechanisms

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to assess the efficacy and safety of hippocampus-targeted deep brain stimulation (DBS) in treatment-resistant schizophrenia. The main question it aims to answer are: * whether patients with treatment-resistant schizophrenia can benefit from hippocampus-targeted DBS; * what is the neural and electrophysiological mechanism underlying the treatment effect of hippocampus-targeted DBS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• Male or female aged between 18 and 55 years.

• Having a diagnosis of schizophrenia according to DSM-IV criteria

• Having a chronic, recurrent course of disease with a five-year minimum duration

• Determined to be treatment-resistant as demonstrated by:

‣ Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.

⁃ Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.

⁃ Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.

⁃ Presence of persistent positive symptom defined as i) requiring a score of 4 (moderate) or more on at least 2 of the next PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.

• Maintaining stable pharmacological treatment for two months preceding screening visit.

• Informed consent

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Dengtang Liu
liudengtang@smhc.org.cn
021-64387986
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 6
Treatments
Active_comparator: On-Stimulation
Disease condition is assessed with stimulation turned on.
Placebo_comparator: Off-Stimulation
Disease condition is assessed with stimulation turned off.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Mental Health Center
Collaborators: Huashan Hospital

This content was sourced from clinicaltrials.gov