Zinc Supplementation of Imipramine Therapy - Full Text View

Sponsor:	Polish Academy of Sciences
Collaborator:	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

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder

Pharmacologic Actions
Behavioral Symptoms
Antidepressive Agents, Tricyclic
Imipramine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009