Does oral N-acetyl-cysteine (NAC) improve schizophrenia symptoms?

Completed

Conditions: Early phase psychosis
Mental and Behavioural Disorders
Schizophrenia

Registration Number: ISRCTN61794329

Lead Sponsor: Swiss National Science Foundation (Fonds National Suisse de la Recherche Scientifique [SNSF]) (Switzerland)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Clinical outcome: decreased risk of relapse during the outcome period measured with the PANSS, GAF and SOFAS)<br>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)<br>3. Functional electroencephalographic outcome: improvement of the MMN (or prevention/delay); change of the P3, response to visual stimuli<br>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.<br>5. Stratification: better response to treatment in sub-groups (high-risk/low risk GCLC genotype and/or anomalies in GSH system)