Zinc Supplementation of Imipramine Therapy

Condition(s) targeted: Major Depression

Intervention: Zincas Forte (Dietary Supplement); Placebo (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: Polish Academy of Sciences

Official(s) and/or principal investigator(s):
Andrzej Zieba, Prof., Principal Investigator, Affiliation: Department of Psychiatry, Collegium Medicum

Examination of the effect of zinc supplementation on imipramine therapy in major depression.

Official title: The Role of Zinc in Therapy of Unipolar Depression

Study design: Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)

Secondary outcome: To assess unwanted side effects in both groups

Detailed description: A placebo-controlled, double blind study of zinc supplementation in imipramine therapy was conducted in sixty, depressed patients fulfilling the DSM-IV criteria for major depression without psychotic symptoms. After a one week washout period, patients were randomized into two groups treated with imipramine and receiving once daily either placebo (n=30) or zinc supplementation (n=30) for 12 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- patients with fulfilled DSM-IV criteria for moderate or severe depressive episode

- one week washout period without any pharmacotherapy

Exclusion Criteria:

- psychotic symptoms

Department of Psychiatry, Collegium Medicum, Jagiellonian University, Krakow 31-501, Poland

Related publications:

Nowak G, Siwek M, Dudek D, Zieba A, Pilc A. Effect of zinc supplementation on antidepressant therapy in unipolar depression: a preliminary placebo-controlled study. Pol J Pharmacol. 2003 Nov-Dec;55(6):1143-7.

Starting date: January 2005
Ending date: April 2006
Last updated: June 9, 2008