N-acetylcysteine in Unipolar depression

The Efficacy of N-acetylcysteine as an Adjunctive Treatment to improving depression in patients with Unipolar Depression: A Double-blind, Randomised, Placebo-controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000134426

Acronym

N-acetylcysteine

Enrollment

120

Registered

2007-02-19

Start date

2007-05-01

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

This is a novel study that investigates the benefits of NAC treatment in unipolar depression. Based on previous literature that reported deficits of this antioxidant in the brains of people with schizophrenia and bipolar disorder, the study postulates the deficits in unipolar depression patients. This trial involves adjunctive treatment where patients are received either NAC or placebo on top of their usual medication for a duration of 8 weeks.

Interventions

N-acetylcysteine will be administered 2mg/day in two 500mg capsules to be taken twice daily for a duration of 8 weeks. Patients will be randomly assigned to N-acetylcysteine.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Have capacity to consent, meet Diagnostic and Statistical Manual for Mental Disorders, Fourth edition, revision (DSM-IV-TR) criteria for major depressive disorder, have single episode or recurrent, achieve score of 18 or over on the MADRS at the time of trial entry, patients on antidepressant therapy need to have been on the same treatment for one month prior to randomisation, and if female of child bearing age and sexually active need to utilise effective contraception.

Exclusion criteria

The exclusion criteria include individuals with concurrent diagnosis of bipolar I or II disorder, bipolar disorder not otherwise specified, electroconvulsive therapy for current depressive episode, concurrent primary diagnosis of a personality disorder, known or suspected clinically unstable systemic medical disorder, elderly subjects with respiratory insufficiency, recent gastrointestinal ulcers, pregnancy or breastfeeding, current use of greater than 500mg of NAC/day, 200mg of selenium or 500 IU of vitamin E/day, and history of anaphylactic reaction to NAC or any component of the preparation.

Outcome results