Zinc Supplementation of Imipramine Therapy - Tabular View

Tracking Information

First Received Date ^ICMJE

June 5, 2008

Last Updated Date

June 9, 2008

Start Date ^ICMJE

January 2005

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00693680 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess unwanted side effects in both groups [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Zinc Supplementation of Imipramine Therapy

Official Title ^ICMJE

The Role of Zinc in Therapy of Unipolar Depression

Brief Summary

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Major Depression

Intervention ^ICMJE

Dietary Supplement: Zincas Forte
Dietary Supplement: Placebo

Study Arms / Comparison Groups

Active Comparator: zinc + imipramine
Placebo Comparator: placebo + imipramine

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2006

Primary Completion Date

April 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT ID ^ICMJE

NCT00693680

Responsible Party

prof. Gabriel Nowak, Institute of Pharmacology, Polish Academy of Sciences

Study ID Numbers ^ICMJE

ZnIMI/2004

Study Sponsor ^ICMJE

Polish Academy of Sciences

Collaborators ^ICMJE

Jagiellonian University

Investigators ^ICMJE

Principal Investigator:

Andrzej Zieba, Prof.

Department of Psychiatry, Collegium Medicum

Information Provided By

Polish Academy of Sciences

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP