Treatment-resistant SchizophreniaNCT05694000
Hippocampus DBS in Treatment-resistant Schizophrenia
A study testing On-Stimulation and Off-Stimulation in people with Treatment-resistant Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Treatment-resistant Schizophrenia
- What is being tested?
- On-Stimulation and Off-Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Dengtang LIU, 18017311138, erliu110@126.com
About this study
Official title: Deep Brain Stimulation of the Ventral Hippocampus in Treatment-resistant Schizophrenia: Exploring the Glutamatergic/GABAergic Mechanisms
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.
Read the detailed description
The first phase of the study will consist of DBS surgery. Participants will receive electrodes implantation in bilateral ventral hippocampus. Continuous stimulation will be applied to optimize and individualize the stimulus parameters. This period is anticipated between 3 and 6 months.
The next phase will consist of the crossover study. Patients who respond to DBS will be randomly assigned to two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.
Participants will receive PET-CT, clinical assessment and cognitive tests at the main study points to evaluate treatment efficacy and patient tolerance, and to reveal the underlying mechanism of the treatment effect of DBS.
- Conditions
- Treatment-resistant Schizophrenia
- Being tested
- On-Stimulation, Off-Stimulation
- Medical subject headings
- Schizophrenia, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-StimulationDevice
The surgical electrode implanted in hippocampus by a pulse generating device is "on".
Off-StimulationDevice
The surgical electrode implanted in hippocampus by a pulse generating device is "off".
| Study group | Role | What they receive |
|---|---|---|
| On-Stimulation | Active comparator | Disease condition is assessed with stimulation turned "on". Receives: Device: On-Stimulation |
| Off-Stimulation | Placebo comparator | Disease condition is assessed with stimulation turned "off". Receives: Device: Off-Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary outcomes (4)
Clinical Global Impression-Schizophrenia (CGI-SCH) Scale
Scale to assess changes in symptoms' severity, global improvement or change
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS) Scale
Scale to assess different dimensions and severity of symptoms
Measured: 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
Battery of neuropsychological tests to assess changes in cognition
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Cerebral metabolism(PET-CT scans)
Assessment of changes in metabolic levels of glutamate, GABA and dopamine in the whole brain using PET-CT
Measured: Baseline, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Nov 2022
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment-resistant SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Huashan Hospital
- Responsible party
- Principal investigator, Dengtang LIU, Shanghai Mental Health Center
- Investigators
- Dengtang Liu, Principal investigator, liudengtang@smhc.org.cn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694000
- Sponsor's protocol ID
- 82171496
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2022
- Last updated
- 23 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39587538
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Ventral Hippocampus in Treatment-resistant Schizophrenia: Exploring the Glutamatergic/GABAergic Mechanisms
- ClinicalTrials.gov ID
- NCT05694000
- Acronym / sponsor ID
- 82171496
- Conditions
- Treatment-resistant Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Huashan Hospital
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The first phase of the study will consist of DBS surgery. Participants will receive electrodes implantation in bilateral ventral hippocampus. Continuous stimulation will be applied to optimize and individualize the stimulus parameters. This period is anticipated between 3 and 6 months.
The next phase will consist of the crossover study. Patients who respond to DBS will be randomly assigned to two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.
Participants will receive PET-CT, clinical assessment and cognitive tests at the main study points to evaluate treatment efficacy and patient tolerance, and to reveal the underlying mechanism of the treatment effect of DBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-Stimulation | Active comparator | Device: On-StimulationDisease condition is assessed with stimulation turned "on". |
| Off-Stimulation | Placebo comparator | Device: Off-StimulationDisease condition is assessed with stimulation turned "off". |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- Maintaining stable pharmacological treatment for two months preceding screening visit.
Key exclusion criteria (7 listed)
- Neurological disease
- Severe physical illness
- Contraindications to neurosurgery, MRI or PET-CT;
- Substance abuse or dependence
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| On-StimulationThe surgical electrode implanted in hippocampus by a pulse generating device is "on". | Device | On-Stimulation |
| Off-StimulationThe surgical electrode implanted in hippocampus by a pulse generating device is "off". | Device | Off-Stimulation |
Primary outcome
Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Scale to assess changes in clinical symptoms; response to DBS is defined as a 20% reduction from baseline in PANSS score
4 secondary outcomes
Clinical Global Impression-Schizophrenia (CGI-SCH) Scale
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Clinician-Rated Dimensions of Psychosis Symptom severity (CRDPS) Scale
Time frame: 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
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Cerebral metabolism(PET-CT scans)
Time frame: Baseline, 24 weeks, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 39587538Lu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dengtang Liu principal investigator
liudengtang@smhc.org.cn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing On-Stimulation and Off-Stimulation in people with Treatment-resistant Schizophrenia, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dengtang Liu (021-64387986, liudengtang@smhc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale for Schizophrenia (PANSS) (time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05694000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.