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Brain Circuitry Therapeutics for Schizophrenia

ConditionSchizophrenia; Psychosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIndrit Begue

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Inclusion criteria

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

Disqualifiers

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.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
at 12 weeks

Secondary outcomes

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

Time frame
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

Time frame
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

Time frame
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

Time frame
at 1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indrit Begue

Lead sponsor

University of Geneva, Switzerland

Sponsor institution

University of Geneva, Switzerland

Collaborator

Source ClinicalTrials.gov
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