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Schizophrenia; PsychosisATHENANCT06341517

Brain Circuitry Therapeutics for Schizophrenia

A study testing iTBS in people with Schizophrenia; Psychosis, run by Indrit Begue at 2 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia; Psychosis
What is being tested?
iTBS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesSwitzerland
Study dates
15 Apr 2024to 12 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • Specific exclusion criteria related to psychopathology
  • 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)

Who cannot join

  • 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
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  • Pacemaker
  • Implanted medication pump
  • Vagal nerve stimulator
  • Deep brain stimulator or TENS unit
  • Ventriculo-peritoneal shunt
  • Cochlear implant
  • Impaired ability to sense heat/pain, open wounds etc.
  • Increased intracranial pressure
  • Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology).
  • History of head injury resulting in prolonged loss of consciousness (>15minutes) or neurological sequelae
  • Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study.
  • Other exclusion criteria
  • Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)
  • Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject
  • Having legal obligation for psychiatric treatment.
  • Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.
  • Previous enrolment into the current investigation
  • Enrolment of the PI, his/her family members, employees and other dependent persons.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland2 sites, 2 recruiting

  • Campus Biotech

    Geneva, 1202

    principal investigator, 0041 58 944 03 00, etude-tms@unige.ch

    Recruiting

  • Indrit Bègue

    Geneva, 1202

    Indrit Bègue, MD, PhD, +41589440300, indrit.begue@unige.ch

    Not yet recruiting

Other trials in Switzerland

About this study

Official title: Brain Circuitry Therapeutics for Schizophrenia - A Cross-species Longitudinal Randomized Controlled Clinical Study to Treat Negative Symptoms of Schizophrenia Using Non-invasive Stimulation of the Cerebellum

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

Read the detailed description

This double-blind RCT aims to explore the efficacy of intensiveTranscranial Magnetic Stimulation (TMS) in schizophrenia spectrum disorders. Previous studies in various disorders suggest that intensive TMS is efficacious and safe.

Participants will undergo neuronavigated intermittent theta burst TMS, targeted to individual network targets, at an accelerated protocol (multiple sessions a day), The primary goal is to determine the efficacy of this protocol in alleviating negative symptoms of schizophrenia.

Additionally, the study will measure the impact of accelerated TMS on a range of clinical and cognitive outcomes, along with neuroimaging markers indicative of symptom response.

Being tested
iTBS
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iTBSDevice

    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

Study groups in NCT06341517
Study groupRoleWhat they receive
ActiveActive comparatorActive intermittent theta burst stimulation (iTBS) to the cerebellum at 80% of active motor threshold.
Receives: Device: iTBS
PlaceboPlacebo comparatorSham intermittent theta burst stimulation (iTBS) to the cerebellum
Receives: Device: iTBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 12 weeks

Secondary outcomes (17)

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

    This outcome measure focuses on the evaluation of apathy and psychosis symptoms

    Measured: at 1 week

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

    This outcome measure focuses on the evaluation of apathy and psychosis symptoms

    Measured: at 6 weeks

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

    This outcome measure focuses on the evaluation of apathy and psychosis symptoms

    Measured: at 12 weeks

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

    This outcome measure focuses on the self-reported evaluation of apathy

    Measured: at 1 week

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

    This outcome measure focuses on the self-reported evaluation of apathy

    Measured: at 6 weeks

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

    This outcome measure focuses on the self-reported evaluation of apathy

    Measured: at 12 weeks

  7. Brief neurocognitive assessment (BNA) scores at follow-up

    This outcome measure focuses on the evaluation of cognitive function

    Measured: at 6 weeks

  8. Auditory Hallucinations Rating Scale (AHRS) scores at follow-up

    This outcome measure focuses on the evaluation of auditory hallucinations

    Measured: at 6 weeks

  9. Calgary Depression Scale (CDSS) scores at follow-up

    This outcome measure focuses on the evaluation of depression symptoms

    Measured: at 6 weeks

  10. Young Mania Rating Scale (YMRS) scores at follow-up

    This outcome measure focuses on the evaluation of mania symptoms

    Measured: at 6 weeks

  11. Personal and social performance scale (PSP) scores at follow-up

    This outcome measure focuses on the evaluation of psychosocial functioning

    Measured: at 12 weeks

  12. Deep-phenotyping outcome - sEBR (spontaneous eye blink)

    This outcome measure focuses on the evaluation of sEBR

    Measured: at 6 weeks

  13. Deep-phenotyping outcome - facial expressions

    This outcome measure focuses on the evaluation of facial expressions

    Measured: at 6 weeks

  14. Deep-phenotyping outcome - accelerometer

    This outcome measure focuses on the evaluation of accelerometry

    Measured: at 6 weeks

  15. Cerebellar-cortical functional connectivity

    This outcome measure focuses on cerebellar-cortical functional connectivity

    Measured: at 1 week

  16. Cerebellar-cortical structural connectivity

    This outcome measure focuses on cerebellar-cortical structural connectivity

    Measured: at 6 weeks

  17. Cerebellar-cortical structural connectivity

    This outcome measure focuses on cerebellar-cortical structural connectivity

    Measured: at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start15 Apr 2024
  3. Primary completion25 Sep 2026 (estimated)
  4. Study completion12 Dec 2027 (estimated)

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341517
Sponsor's protocol ID
BASEC-ID:2023-D0117
Acronym
ATHENA
Status last verified
Nov 2024
First submitted
4 Dec 2023
Last updated
19 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing iTBS in people with Schizophrenia; Psychosis, run by Indrit Begue at 2 sites in Switzerland.

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 12 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: at 12 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 NCT06341517.

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 19 Nov 2024.

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