Brain Circuitry Therapeutics for Schizophrenia

NCT06341517 | Recruiting DMC

• 1 other identifier: BASEC-ID:2023-D0117
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia

Conditions

Schizophrenia; Psychosis

Outcome Measures

Primary Outcomes (1)

• Brief Negative Symptoms Scale - apathy subscale (BNSS-Apathy) at follow-up (FU) at T3. The primary endpoint will be assessed at baseline and all follow-up visits at week 1, 6 and 12.

  This outcome measure focuses on the evaluation of changes in apathy symptoms in participants, utilizing the apathy subscale of the Brief Negative Symptoms Scale (BNSS-Apathy). Apathy symptoms will be assessed at baseline (pre-intervention) and subsequently at follow-up visits scheduled at weeks 1, 6, and 12 post-intervention. The primary endpoint of this measure is the change in BNSS-Apathy scores from baseline to each follow-up point, aiming to capture the trajectory of symptom changes across the study period. The BNSS-Apathy subscale score, derived from specific item responses, provides a quantitative measure of apathy severity, allowing for statistical analysis of symptom changes over time. Higher scores reflect greater severity of symptoms. Maximum score of BNSS-Apathy subscale score is 42 (severe apathy), minimum score is 0.

  at 12 weeks

Secondary Outcomes (17)

• Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up

  at 1 week

• Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up

  at 6 weeks

• Positive and Negative Symptoms Scale (PANSS) positive and negative subscores at follow-up

  at 12 weeks

• Self reported Negative Scale SNS scores and its sub-scales at follow-up

  at 1 week

• Self reported Negative Scale SNS scores and its sub-scales at follow-up

  at 6 weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

Active intermittent theta burst stimulation (iTBS) to the cerebellum at 80% of active motor threshold.

Device: iTBS

Placebo

PLACEBO COMPARATOR

Sham intermittent theta burst stimulation (iTBS) to the cerebellum

Device: iTBS

Interventions

iTBS DEVICE

Intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses for up to 8 sessions daily for 5 days

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of giving informed consent as evaluated by the treating psychiatrist
• Informed Consent signed by the subject
• Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria
• Clinically stable condition judged by their treating psychiatrist
• Background antipsychotic medication treatments have remained unchanged for at least 4 weeks
• No hospitalization in acute psychiatry ward at least 3 months prior to study entry

You may not qualify if:

• Comorbid and clinically active current major depressive episode determined by the treating psychiatrist.
• Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness/persecution and hallucinatory behaviour will be considered not stable enough to participate.
• Significant extrapyramidal side-effects quantified by total score of mSAS \> 12.
• Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.)
• Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)
• History of fainting spells of unknown or undetermined aetiology that might constitute seizures
• History of multiple seizures or diagnosis of epilepsy
• Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease
• Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
• Metallic objects/implants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement)
• Any implants controlled by physiological signs in/near the head
• Pacemaker
• Implanted medication pump
• Vagal nerve stimulator
• Deep brain stimulator or TENS unit

Sponsors & Collaborators

• Indrit Begue: lead
• University of Geneva, Switzerland: collaborator

Study Sites (2)

Campus Biotech

Geneva, 1202, Switzerland

RECRUITING

Indrit Bègue

Geneva, 1202, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects, care providers, investigators and outcome assessors will all be blinded as to the randomization sequence, and thus will be blinded as to sham vs active TMS status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: April 2, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): December 12, 2027
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CH (2)