Hippocampus DBS in Treatment-resistant Schizophrenia
Deep Brain Stimulation of the Ventral Hippocampus in Treatment-resistant Schizophrenia: Exploring the Glutamatergic/GABAergic Mechanisms
1 other identifier
interventional
6
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJanuary 23, 2023
January 1, 2023
2.1 years
December 9, 2022
January 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Scale to assess changes in clinical symptoms; response to DBS is defined as a 20% reduction from baseline in PANSS score
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary Outcomes (4)
Clinical Global Impression-Schizophrenia (CGI-SCH) Scale
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS) Scale
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
The Chinese version of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Cerebral metabolism(PET-CT scans)
Baseline, 24 weeks, 48 weeks
Other Outcomes (1)
Adverse events (AEs)
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Study Arms (2)
On-Stimulation
ACTIVE COMPARATORDisease condition is assessed with stimulation turned "on".
Off-Stimulation
PLACEBO COMPARATORDisease condition is assessed with stimulation turned "off".
Interventions
The surgical electrode implanted in hippocampus by a pulse generating device is "on".
The surgical electrode implanted in hippocampus by a pulse generating device is "off".
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Neurological disease
- Severe physical illness
- Contraindications to neurosurgery, MRI or PET-CT;
- Substance abuse or dependence
- Mental retardation
- Female patients who are pregnant or breastfeeding
- Severe suicide risk and tendencies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Mental Health Centerlead
- Huashan Hospitalcollaborator
Study Sites (1)
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030, China
Related Publications (1)
Lu C, Zhai Z, Zhuo K, Xiang Q, Xue J, Zhao Y, Lang L, Shao C, Chen L, Liu D. Deep brain stimulation of Hippocampus in Treatment-resistant Schizophrenia (DBS-HITS): protocol for a crossover randomized controlled trial. BMC Psychiatry. 2024 Nov 25;24(1):847. doi: 10.1186/s12888-024-06318-6.
PMID: 39587538DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dengtang Liu
liudengtang@smhc.org.cn
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Psychiatrist and Professor
Study Record Dates
First Submitted
December 9, 2022
First Posted
January 23, 2023
Study Start
November 1, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
January 23, 2023
Record last verified: 2023-01