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Zinc Supplementation of Imipramine Therapy

NCT ID: NCT00693680

Last Updated: 2008-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Major Depression

Keywords

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depression antidepressant treatment zinc placebo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

zinc + imipramine

Group Type ACTIVE_COMPARATOR

Zincas Forte

Intervention Type DIETARY_SUPPLEMENT

25 mgZn/day + imipramine (100-200mg/day)

2

placebo + imipramine

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo + imipramine (100-200mg/day)

Interventions

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Zincas Forte

25 mgZn/day + imipramine (100-200mg/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo + imipramine (100-200mg/day)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Zincas Forte (Farmapol, Poland) Imipramin (Polfarma, Poland) Imipramin (Polfarma, Poland)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jagiellonian University

OTHER

Sponsor Role collaborator

Polish Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Institute of Pharmacology, Polish Academy of Sciences

Principal Investigators

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Andrzej Zieba, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Collegium Medicum

Locations

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Department of Psychiatry, Collegium Medicum, Jagiellonian University

Krakow, , Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 14730113 (View on PubMed)

Other Identifiers

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ZnIMI/2004

Identifier Type: -

Identifier Source: org_study_id