Hippocampus DBS in Treatment-resistant Schizophrenia

Last updated: January 19, 2023
Sponsor: Shanghai Mental Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mood Disorders

Tourette's Syndrome

Psychosis

Treatment

N/A

Clinical Study ID

NCT05694000
82171496
  • Ages 18-55
  • All Genders

Study 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 Criteria

Inclusion

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 appropriatetreatments for at least 2 years.
  2. Inadequate response from adequate trials of two different classes ofantipsychotic drugs (not including clozapine), at least 8 weeks.
  3. Inadequate response from adequate trial of clozapine, at least 3 months, orunable 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, conceptualdisorganization, hallucinatory behavior, suspiciousness and unusual thoughtcontent; or as ii) requiring a score of 6 (severe) or more on at least 1 of theabove PANSS items.
  • Maintaining stable pharmacological treatment for two months preceding screening visit.
  • Informed consent

Exclusion

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

Study Design

Total Participants: 6
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Shanghai Mental Health Center

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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