Status:
NOT_YET_RECRUITING
Stratifying Psychoses for Personalized REpetitive TMS in Persistent NEgative Symptoms Alleviation
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Schizophrenia
Persistent Negative Symptoms
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
In its 2012's release guideline on therapy for schizophrenia, the EMA joined the FDA to acknowledge primary and persistent negative symptoms (PNS) as an unmet need in the treatment of schizophrenia. F...
Eligibility Criteria
Inclusion
- 18-70 years of age; affiliated to health insurance; superior or equal to B2 level of linguistic competency in French.
- Suffering from schizophrenia spectrum disorder (SSD) in residual state with persistent negative symptoms (PNS): (1) SSD: ICD-11 codes beginning with 6A2 + primary catatonia (codes beginning with 6A4) + simple schizophrenia as defined in ICD-10 (F20.6); (2) PNS: persistence (≥6 months - based on patient ± informant's interview) of ≥2 negative symptoms (PANSS-N1, N2, N3, N4, N6 ≥4) with functional impact.
- Half of subjects having PPC, the other half suffering from another phenotype or nPPC (neuropsychiatric procedure or probabilistic, i.e. Bayes-PPC).
- Under a stable medication regimen for \>6 weeks,
- Subjects who have received the protocol information and signed informed consent.
Exclusion
- \- Contraindications for MRI or rTMS.
- Motor deficit at neurological examination.
- Secondary negative symptoms: (1) withdrawal secondary to severe anxiety (especially due to positive symptoms), (2) depression, (3) maintenance on high dose antipsychotics, (4) extra-pyramidal or (5) sedation side-effects, (6) treatment non-compliance, (7) current substance abuse (except nicotine and caffeine), (8) unsubstituted past opioid addiction, (9) poor health or social condition.
- Under antiepileptic drugs (except lamotrigine and long-term use of benzodiazepines).
- Pregnancy; severe medical condition; care under constraint.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06184165
Start Date
March 1 2024
End Date
November 1 2028
Last Update
December 28 2023
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