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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01506765
• Date of registration: 03/01/2012
• Primary sponsor: Centre Hospitalier Universitaire Vaudois
• Public title: 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
• Scientific title: 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: Double-blind and Crossover Study
• Date of first enrolment: August 2003
• Target sample size: 13
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01506765
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Contacts

• Name: Kim Do, Professor
• Affiliation: CNP/ LUNEP

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients (male or female, aged 18 to 65 years, QI>70) meeting the DSM-IV criteria
(established by a senior psychiatrist) for schizophrenia and have the capacity to
consent to the study. The study population include both inpatients and outpatients
who are currently taking at least one of the following:Olanzapine, Clozapine,
Haloperidol, Risperidone, Flupenthixol, or Fluphenazine. The following guidelines
have been established for potential medication changes that patients may undergo
during the course of the trial.

- dose changes to existing medication (either increases or decreases in dose) will be
accepted and participants will be allowed to continue with the trial.

- A change in primary antipsychotics from one medication to another will require
participants to withdrawn from the study.

- An addiction of another antipsychotic, secondary to the existing antipsychotic
treatment (primary antipsychotic) will be acceptable providing that there isn't a
complete change from one antipsychotic to another.

Exclusion Criteria:

- pregnancy

- acute psychotic state, preventing the patient cooperation

- co-morbidity with drug dependency

- organic cerebral disease, major somatic diseases

- abnormal renal, hepatic, thyroid or hematological findings

- treatment with a regulator of mood(lithium, valproate, topiramate, lamotrigine et
carbamazepine)

- allergy to NAC

- treatment with antioxidants



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: N-Acetyl-Cysteine (NAC)

Primary Outcome(s)

Positive and Negative Syndrome Scale (PANSS) [Time Frame: 8 months]

Secondary Outcome(s)

• Magnetic Resonance Spectroscopy (MRS) [Time Frame: 8 months]

Blood and fibroblasts biochemistry [Time Frame: 8 months]

Clinical Global Impression - (CGI) [Time Frame: 8 months]

EEG/evoked potentials [Time Frame: 8 months]

frankfurt Complaint Questionnaire (FCQ) [Time Frame: 8 months]

Global Assessment of Functioning - (GAF) [Time Frame: 8 months]

Neurological scales for the assessment of extrapyramidal symptoms [Time Frame: 8 months]

Neuropsychological evaluation [Time Frame: 8 months]

Secondary ID(s)

106/03 CE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors