Acetyl Cysteine In Schizophrenia Resistant To Clozapine: A Double-Blind Randomised Placebo-Controlled Trial Targeting Negative Symptoms

Phase 4

• Conditions: Schizophrenia resistant to clozapine; Mental Health - Schizophrenia

• Registration Number: ACTRN12615001273572
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-23
• Study Completion: 2020-02-10
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

To be included the participants will be required to meet DSM5 criteria for SZ and:
- Have been on clozapine at an adequate dose, ascertained by a serum level of >350mcg/L for at least 6 months with residual symptom
- Have a PANSS score of 60 or at least two negative symptom items of >4
- Have the capacity to consent to the study
- Aged between 18 and 65 years
- Be utilising effective contraception if female and of childbearing age

Exclusion Criteria

- Participants who are currently taking NAC
- Participants who are allergic to NAC or any component of the preparation
- Inability to comply with either the requirements of informed consent or the treatment protocol.
- People taking nitro-glycerine
- Diabetics on insulin replacement
- People taking Selenium or Vitamin E

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
egative symptoms as assessed with the Positive and Negative Symptoms Scale (PANSS)[8, 24 and 52 weeks.]

Secondary Outcome Measures

Name	Time	Method
Cognition as assessed by the MATRICS.[8,24 and 52 weeks];Quality of life as assessed by the Manchester Short Assessment of Quality of Life (MANSA) and the Assessment of Quality of Life (AQoL) [8, 24 and 52 weeks];Peripheral and cortical glutathione concentrations as assessed through blood samples and magnetic resonance spectroscopy, respectively.[8, 24 and 52 weeks];Biomarkers pertinent to glutathione (including thiols (such as GSH, cysteine, cysteinyl-glycine, N-acetylcysteine) and corresponding disulphides (such as glutathione disulphide (GSSG) and cysteine), other markers of oxidative stress (lipid peroxidation – thiobarbaturic acid -TBARS, DNA damage - 8-oxoguanine and protein carbonylation) and antioxidant levels).[8, 24 and 52 weeks]