ACTRN12607000134426
Completed
Phase 3
The Efficacy of N-acetylcysteine as an Adjunctive Treatment to improving depression in patients with Unipolar Depression: A Double-blind, Randomised, Placebo-controlled Trial
Mental Health Research Institute0 sites120 target enrollmentFebruary 19, 2007
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- nipolar depression
- Sponsor
- Mental Health Research Institute
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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