Zinc Supplementation of Imipramine Therapy

June 9, 2008 updated by: Polish Academy of Sciences

The Role of Zinc in Therapy of Unipolar Depression

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
zinc + imipramine
Dietary supplement: Zincas Forte
25 mgZn/day + imipramine (100-200mg/day)
Other Names:
  • Zincas Forte (Farmapol, Poland)
  • Imipramin (Polfarma, Poland)
PLACEBO_COMPARATOR: 2
placebo + imipramine
Dietary supplement: Placebo
placebo + imipramine (100-200mg/day)
Other Names:
  • Imipramin (Polfarma, Poland)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess unwanted side effects in both groups
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polish Academy of Sciences

Collaborators

Jagiellonian University

Investigators

  • Principal Investigator: Andrzej Zieba, Prof., Department of Psychiatry, Collegium Medicum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (ACTUAL)

April 1, 2006

Study Completion (ACTUAL)

April 1, 2006

Study Registration Dates

First Submitted

June 5, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (ESTIMATE)

June 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2008

Last Update Submitted That Met QC Criteria

June 9, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZnIMI/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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