Effects of N-acetylcysteine on substance use in bipolar disorder: A randomised placebo-controlled clinical trial.

OBJECTIVE: To evaluate the effect of N-acetylcysteine (NAC) on substance use in a double-blind, placebo-controlled trial of NAC in bipolar disorder. It is hypothesised that NAC will be superior to placebo for reducing scores on the Clinical Global Impressions scale for Substance Use (CGI-SU). METHODS: Participants were randomised to a 6-months of treatment with 2 g/day NAC (n = 38) or placebo (n = 37). Substance use was assessed at baseline using a Habits instrument. Change in substance use was assessed at regular study visits using the CGI-SU. RESULTS: Among the 75 participants 78.7% drank alcohol (any frequency), 45.3% smoked tobacco and 92% consumed caffeine. Other substances were used by fewer than six participants. Caffeine use was significantly lower for NAC-treated participants compared to placebo at week 2 of treatment but not at other study visits. CONCLUSIONS: NAC appeared to have little effect on the participants who were using substances. A larger study on a substance-using population will be necessary to determine if NAC may be a useful treatment for substance use.

Effects of N-acetylcysteine on substance use in bipolar disorder: a randomised placebo-controlled clinical trial.

OBJECTIVE: To evaluate the effect of N-acetylcysteine (NAC) on substance use in a double-blind, placebo-controlled trial of NAC in bipolar disorder. It is hypothesised that NAC will be superior to placebo for reducing scores on the Clinical Global Impressions scale for Substance Use (CGI-SU). METHODS: Participants were randomised to 6-months of treatment with 2 g/day NAC (n = 38) or placebo (n = 37). Substance use was assessed at baseline using the Habits instrument. Change in substance use was assessed at regular study visits using the CGI-SU. RESULTS: Amongst the 75 participants 78.7% drank alcohol (any frequency), 45.3% smoked tobacco and 92% consumer caffeine. Other substances were used by fewer than six participants. Caffeine use was significantly lower for NAC-treated participants compared with placebo at week 2 of treatment but not at other study visits. CONCLUSION: NAC appeared to have little effect on substance use in this population. A larger study on a substance using population will be necessary to determine if NAC may be a useful treatment for substance use.

The validity of the CGI severity and improvement scales as measures of clinical effectiveness suitable for routine clinical use.

OBJECTIVE: The Clinical Global Impression Scale (CGI) is established as a core metric in psychiatric research. This study aims to test the validity of CGI as a clinical outcome measure suitable for routine use in a private inpatient setting. METHODS: The CGI was added to a standard battery of routine outcome measures in a private psychiatric hospital. Data were collected on consecutive admissions over a period of 24 months, which included clinical diagnosis, demographics, service utilization and four routine measures (CGI, HoNOS, MHQ-14 and DASS-21) at both admission and discharge. Descriptive and comparative data analyses were performed. RESULTS: Of 786 admissions in total, there were 624 and 614 CGI-S ratings completed at the point of admission and discharge, respectively, and 610 completed CGI-I ratings. The admission and discharge CGI-S scores were correlated (r = 0.40), and the indirect improvement measures obtained from their differences were highly correlated with the direct CGI-I scores (r = 0.71). The CGI results reflected similar trends seen in the other three outcome measures. CONCLUSIONS: The CGI is a valid clinical outcome measure suitable for routine use in an inpatient setting. It offers a number of advantages, including its established utility in psychiatric research, sensitivity to change, quick and simple administration, utility across diagnostic groupings, and reliability in the hands of skilled clinicians.