Zinc Supplementation of Imipramine Therapy - Full Text View

Sponsors and Collaborators:	Polish Academy of Sciences Jagiellonian University
Information provided by:	Polish Academy of Sciences
ClinicalTrials.gov Identifier:	NCT00693680

Purpose

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

Condition	Intervention
Major Depression	Dietary Supplement: Zincas Forte Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Role of Zinc in Therapy of Unipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression Dietary Supplements Diets

Drug Information available for: Imipramine Imipramine hydrochloride

U.S. FDA Resources

Further study details as provided by Polish Academy of Sciences:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:	60
Study Start Date:	January 2005
Study Completion Date:	April 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator zinc + imipramine	Dietary Supplement: Zincas Forte 25 mgZn/day + imipramine (100-200mg/day)
2: Placebo Comparator placebo + imipramine	Dietary Supplement: Placebo placebo + imipramine (100-200mg/day)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00693680

Locations

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

Sponsors and Collaborators

Polish Academy of Sciences

Jagiellonian University

Investigators

Principal Investigator:

Andrzej Zieba, Prof.

Department of Psychiatry, Collegium Medicum

More Information

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.

Responsible Party:	Institute of Pharmacology, Polish Academy of Sciences ( prof. Gabriel Nowak )
Study ID Numbers:	ZnIMI/2004
Study First Received:	June 5, 2008
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00693680 History of Changes
Health Authority:	Poland: Ministry of Health

Keywords provided by Polish Academy of Sciences:

depression
antidepressant treatment
zinc
placebo

Study placed in the following topic categories:

Imipramine
Depression
Mental Disorders
Zinc
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 02, 2009