A double blind randomised placebo controlled trial of NAC in bipolar disorder.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12607000074493
• Date of registration: 23/01/2007
• Prospective Registration: Yes
• Primary sponsor: Stanley Medical Research Institute
• Public title: A double blind randomised placebo controlled trial of NAC in bipolar disorder.
• Scientific title: An investigation of the effects of n-acetyl cysteine in bipolar disorder based on time to intervention for mood symptoms and a range of psychiatric rating scales.
• Date of first enrolment: 01/03/2007
• Target sample size: 150
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12607000074493.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Other;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Australia

Contacts

• Name: Professor Michael Berk

• Name: Professor Michael Berk

Key inclusion & exclusion criteria

Inclusion criteria: Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for bipolar disorder, have current symtpoms of depression with a Montgomery-Asberg Depression Rating Scale (MADRS) score over 12 at baseline, have the capacity to consent, be on stable therapy for at least one month prior to randomisation.
Exclusion criteria: Individuals with a known or suspected clinically relevant medical disorder, elderly individuals with respiratory insufficiency, individuals who are pregnant or lactating, individuals currently taking greater than 500 mg/day of NAC, 200 ug of slenium/day or 500 International Units (IU) of vitamin E/day, individuals who have had previous anaphylactic reactions to NAC or any component of the preparation.

Age minimum: 18 Years
Age maximum: Not stated
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Bipolar disorder;
Bipolar disorder

Mental Health - Other mental health disorders

Intervention(s)

Oral n-acetyl cysteine (NAC) treatment (2 grams per day) will be provided in an open label design for the first two months. Participants will continue on the trial for an additional six months and will be randomly assigned to NAC.

Primary Outcome(s)

Time to intervention for mood symptoms will be the primary outcome for this study. [Assessed following the open label phase, at each monthly visit for the duration of the randomised trial (six months).]

Secondary Outcome(s)

Secondary outcomes include but are not limited to the following rating scales; Montgomery-Asberg Depression Rating Scale (MADRS), Bipolar Depression Rating Scale (BDRS), Young Mania Rating Scale (YMRS), Clincial Global Impression (CGI) improvement and severity scales, Clinical Global Impression for Bipolar Disorder (CGIBP), Global Assessment of Functioning Scale (GAF), Social and Occupational Functioning Assessment Scale (SOFAS), Streamlined Longitudinal Interview Clinical Evaluation from the Longitudinal Interval Follow-up Evaluation (SLICE/LIFE), Range of Impaired Functioning Tool (LIFE/RIFT), Life Functioning Questionairre (LFQ), Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), cognitive testing, and investigations of blood for oxidative markers. [These will be assessed during the open label phase (three fortnightly visits) and at each visit of the randomised trial (six monthly visits).]

Secondary ID(s)

NAC BD2

Source(s) of Monetary Support

Stanley Medical Research Institute Grant

Secondary Sponsor(s)

Mental Health Research Institute

Ethics review

Status: Approved
Approval date:
Contact:

Barwon Health

Status: Approved
Approval date:
Contact:

Bendigo Health Care Group

Status: Approved
Approval date:
Contact:

Southwestern Mental Health Service