acetyl cysteine in schizophrenia: A double blind randomised placebo controlled trial

Phase 3

Completed

• Conditions: Schizophrenia; Mental Health - Schizophrenia

• Registration Number: ACTRN12605000363684
• Lead Sponsor: Stanley Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

DSM-IV diagnosis of schizophrenia, have a PANSS score of >55 or at least two items in the positive and/or negative items being >3 AND/OR have a CGI-S >3, be utilising effective contraception if of child-bearing age.

Exclusion Criteria

Taking mood stabilisers, asthma or history of respiratory insufficiency/allergy to n-acetyl cysteine, abnormal heamotological findings, or systemic medical disorder, currently taking either 500mg of NAC/day, 200ug of selenium/day or 500 IU of Vitamin E/day or inability to comply with the informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PANSS[Used at each of the 10 visits over a 6 month period.];GAF[Used at each of the 10 visits over a 6 month period.];SOFAS[Used at each of the 10 visits over a 6 month period.];CGI[Used at each of the 10 visits over a 6 month period.];Cognitive testing[Used at each of the 10 visits over a 6 month period.];Assessment of involuntary movements[Used at each of the 10 visits over a 6 month period.]

Secondary Outcome Measures

Name	Time	Method
Safety data such as blood pressure, BMI, and routine blood testing.[Blood pressure and BMI are taken at each visit whereas blood collection/testing is carried out at baseline and two months into the trial.]