Deep brain stimulation for treatment-resistant schizophrenia

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

This study is testing if deep brain stimulation can help people with schizophrenia who haven't responded to other treatments feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05694000 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and efficacy of deep brain stimulation (DBS) targeting the hippocampus in patients with treatment-resistant schizophrenia. Initially, participants will undergo surgery for electrode implantation in the bilateral ventral hippocampus, followed by a continuous stimulation phase lasting 3 to 6 months. Afterward, a crossover study will assess the effects of stimulation by alternating between on and off stimulation groups for 3 months each. Throughout the study, participants will undergo PET-CT scans, clinical assessments, and cognitive tests to measure treatment efficacy and understand the underlying mechanisms of DBS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 with a diagnosis of treatment-resistant schizophrenia lasting at least five years.

Not a fit: Patients who do not meet the criteria for treatment-resistant schizophrenia or are outside the age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief for patients suffering from treatment-resistant schizophrenia.

How similar studies have performed: While deep brain stimulation has been explored in various neurological and psychiatric conditions, this specific application for treatment-resistant schizophrenia is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* 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:

  1. Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
  2. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
  3. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
  4. 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

Exclusion Criteria:

* 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

Where this trial is running

Shanghai, Shanghai

• Shanghai Mental Health Center — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Dengtang Liu — [e-mail]
• Study coordinator: Dengtang Liu

Conditions: Treatment-resistant Schizophrenia