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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000074493

Enrollment

150

Registered

2007-01-23

Start date

2007-03-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To evaluate the efficacy of n-acetyl cysteine treatment in individuals with bipolar disorder who are continuing treatment as usual with the adjuct of n-acetyl cysteine treatment.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Other

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

Outcome results