Back to Search
Start Over
N-acetylcysteine (NAC) in schizophrenia resistant to clozapine: a double blind randomised placebo controlled trial targeting negative symptoms
- Source :
- BMC Psychiatry
- Publication Year :
- 2016
- Publisher :
- BioMed Central, 2016.
-
Abstract
- Clozapine is an effective treatment for a proportion of people with schizophrenia (SZ) who are resistant to the beneficial effects of other antipsychotic drugs. However, anything from 40–60 % of people on clozapine experience residual symptoms even on adequate doses of the medication, and thus could be considered ‘clozapine resistant’. Agents that could work alongside clozapine to improve efficacy whilst not increasing the adverse effect burden are both desired and necessary to improve the lives of individuals with clozapine-resistant SZ. N-Acetylcysteine (NAC) is one such possible agent. Previous research from our research group provided promising pilot data suggesting the efficacy of NAC in this patient population. The aim of the study reported here is to expand this work by conducting a large scale clinical trial of NAC in the treatment of clozapine-resistant SZ. This study is an investigator initiated, multi-site, randomised, placebo-controlled trial. It aims to include 168 patients with clozapine-resistant SZ, divided into an intervention group (NAC) and a control group (placebo). Participants in the intervention group will receive 2 g daily of NAC. The primary outcome measures will be the negative symptom scores of the Positive and Negative Syndrome Scale (PANSS). Secondary outcome measures will include: changes in quality of life (QoL) as measured by the Lancashire Quality of Life Profile (LQoLP) and cognitive functioning as measured by the total score on the MATRICS. Additionally we will examine peripheral and cortical glutathione (GSH) concentrations as process outcomes. This large scale clinical trial will investigate the efficacy of NAC as an adjunctive medication to clozapine. This trial, if successful, will establish a cheap, safe and easy-to-use agent (NAC) as a ‘go to’ adjunct in patients that are only partly responsive to clozapine. Australian and New Zealand Clinical Trials Registration Number: Current Randomised Controlled Trial ACTRN12615001273572 . The date of registration 23 November 2015.
- Subjects :
- Male
medicine.medical_treatment
Placebo-controlled study
Drug Resistance
N-Acetylcysteine
law.invention
Study Protocol
0302 clinical medicine
Cognition
Randomized controlled trial
law
Medicine
Clozapine
Positive and Negative Syndrome Scale
Free Radical Scavengers
Middle Aged
3. Good health
Psychiatry and Mental health
Treatment Outcome
Female
Schizophrenic Psychology
Negative Symptoms
medicine.drug
Antipsychotic Agents
Adult
medicine.medical_specialty
Adolescent
Placebo
03 medical and health sciences
Young Adult
Double-Blind Method
Internal medicine
Humans
Psychiatry
Antipsychotic
Aged
Risperidone
business.industry
Australia
030227 psychiatry
Acetylcysteine
Clinical trial
Schizophrenia
Quality of Life
business
030217 neurology & neurosurgery
Biomarkers
Follow-Up Studies
New Zealand
Subjects
Details
- Language :
- English
- ISSN :
- 1471244X
- Volume :
- 16
- Database :
- OpenAIRE
- Journal :
- BMC Psychiatry
- Accession number :
- edsair.doi.dedup.....e4a32f6d7e865d2ecd14204011b56a4b