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Completed

NCT Number: NCT00693680

Zinc Supplementation of Imipramine Therapy

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

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Key information

Conditions

Major Depression Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Collegium Medicum, Jagiellonian University

Krakow, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zincas Forte

Dietary Supplement

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

Other names: Zincas Forte (Farmapol, Poland), Imipramin (Polfarma, Poland)

Placebo

Dietary Supplement

placebo + imipramine (100-200mg/day)

Other names: Imipramin (Polfarma, Poland)

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

  1. To assess unwanted side effects in both groups

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Polish Academy of Sciences

Other

Collaborators

  • Jagiellonian University

Registry information

Official study title

The Role of Zinc in Therapy of Unipolar Depression

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jun 9, 2008
Registry last updated
Jun 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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