Schizophrenia, Related Troubles and Glutathione: Clinical Trial. Effects of Oral Administration of N-Acetylcysteine (NAC) on the Brain Glutathione Level and on the Symptoms of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The results of the study "schizophrenia, related disorders and glutathione" conducted at the
      Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis
      proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia
      at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now
      to try to restore a higher level of glutathione in patients to see if this increase is
      accompanied by an improvement in symptoms, particularly negative symptoms and disorders
      cognitive, particularly resistant to current therapy. N-acetyl-cystein (NAC) is a precursor
      of glutathione which is used clinically for various indications, well tolerated even at high
      doses. The investigators propose a double-blind cross-over with the aim to study if the
      N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain
      (measured in resonance magnetic spectroscopic) and also improved patients' conditions
      (determined by clinical assessments, psychopathological, neuropsychological, biochemical and
      physiological), while recording any side effects. As a first step, this study should include
      at least thirty patients and last for two to three years. It is important to note that this
      is not a study of medication suggested by a pharmaceutical industry, but a medical search.
    

Detailed description: 
      The results of the study "schizophrenia, related disorders and glutathione" conducted at the
      Laboratory of Psychiatric Neuroscience (LUNEP) DUPA of Lausanne, reinforce the hypothesis
      proposed that a deficit intracerebral glutathione is a vulnerability factor for Schizophrenia
      at least for a subgroup of patients. While pursuing the baseline study, it is appropriate now
      to try to restore a higher level of glutathione in patients to see if this increase is
      accompanied by an improvement in symptoms, particularly negative symptoms and disorders
      cognitive, particularly resistant to current therapy. N-acetyl-cysteine (NAC) is a precursor
      of glutathione which is used clinically for various indications, well tolerated even at high
      doses. The investigators propose a double-blind cross-over with the aim to study if the
      N-acetyl-cystein (at a dose of oral 2g/day) leads on the one hand a rising glutathione brain
      (measured in resonance magnetic spectroscopic) and also improved patients' conditions
      (determined by clinical assessments, psychopathological, neuropsychological, biochemical and
      physiological), while recording any side effects. As a first step, this study should include
      at least thirty patients and last for two to three years. It is important to note that this
      is not a study of medication suggested by a pharmaceutical industry, but a medical search.
    

Intervention name(s): N-Acetyl-Cysteine (NAC)
Intervention type(s): Drug
Intervention description(s): Once included, the patients will be randomly placed in two groups: one group (1) will receive 2 g/day of NAC (2caps of 0.5g twice a day) and the other group (2) a placebo, for a duration of 8 weeks. At the end of the 8 weeks, group (2) will receive NAC and (1) the placebo for another 8 weeks
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; glutathione; NAC; Neurological scales; Magnetic Resonance Spectroscopy (MRS); EEG/evoked potentials; fibroblasts; patients who receive NAC; patients who receive placebo