acetylcysteine in Unipolar depressio

Phase 3

Completed

• Conditions: nipolar depression; Unipolar depression; Mental Health - Depression

• Registration Number: ACTRN12607000134426
• Lead Sponsor: Mental Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Montgomery Asberg depression Rating Scale (MADRS)[The scale will be administered at weeks 2, 4, 6 and 8 post-baseline intervals]

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes include Clinical Global Impression - Improvement (CGI-I) and Severity (CGI-S), Global Assessment of Functioning Scale (GAF), Social and Occupational Functioning Assessment Scale (SOFAS), SLICE LIFE/LIFE RIFT, Quality of life Enjoyment & Satisfaction Questionnaire (Q-Les-Q).[These scales will be administered at weeks 2, 4, 6, and 8 post-baseline intervals.]