Early phase psychosis Mental and Behavioural Disorders Schizophrenia
Conditions
Interventions
Each patient gets 2700 mg NAC or placebo per day during 24 weeks. Each patient gets the NAC pills/placebo each month for four weeks. After 24 weeks we stop the NAC/placebo and there is a follow-up aft
Sponsors
Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Capability to provide informed consent 2. Male or female aged 15 to 35 years with sufficient command of French language 3. Having met threshold criteria for psychosis as defined by the "Psychosis threshold" subscale of the Comprehensive Assessment of at Risk Mental States Scale (CAARMS). This threshold is based on a combination of intensity and duration of psychotic symptoms.
Exclusion criteria
Exclusion criteria: 1. Severe somatic comorbidities: peptic ulcer disease, chronic inflammatory pathologies, infectious pathologies including human immunodeficiency virus (HIV), pathologies of the immune system, organic cerebral diseases, tumours, abnormal renal, hepatic, thyroid or haematological findings 2. Previous cerebral trauma 3. Substance induced psychosis or organic psychosis 4. Mental retardation (intellectual quotient [IQ] less than 70 and alteration or significant adaptation deficit). We will assess the IQ only in the case of necessity when we doubt about the intellectual skills of a patient. 5. NAC allergy 6. Treatment with antioxidants (vitamin E, selenium, multivitamins, etc.) 7. Insufficient command of French
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of the negative symptoms, measured with the Positive and Negative Syndrome Scale (PANSS - score: 1 = absence of the symptom to 7 = extreme symptoms), measured at baseline, then every month for 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical outcome: decreased risk of relapse during the outcome period measured with the PANSS, GAF and SOFAS) 2. Neuropsychological outcome: improvement of cognition (measured with the global score of the "MATRICS" battery); and improvement of the working memory (measured with the "MATRICS" battery) 3. Functional electroencephalographic outcome: improvement of the MMN (or prevention/delay); change of the P3, response to visual stimuli 4. Magnetic resonance by spectroscopy (MRS): higher cerebral level of glutathione measured by MRS. Changes in connectivity measured by MRS and DSI, diffusion spectrum imaging. Measured at baseline (V1) and after 6 months. 5. Stratification: better response to treatment in sub-groups (high-risk/low risk GCLC genotype and/or anomalies in GSH system) | — |
Countries
Switzerland, United States of America
Outcome results
None listed