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Zinc Supplementation of Imipramine Therapy

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Zincas Forte
Placebo
Sponsored by
Polish Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, antidepressant treatment, zinc, placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry, Collegium Medicum, Jagiellonian University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

zinc + imipramine

placebo + imipramine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess unwanted side effects in both groups

Full Information

First Posted
June 5, 2008
Last Updated
June 9, 2008
Sponsor
Polish Academy of Sciences
Collaborators
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT00693680
Brief Title
Zinc Supplementation of Imipramine Therapy
Official Title
The Role of Zinc in Therapy of Unipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Polish Academy of Sciences
Collaborators
Jagiellonian University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
depression, antidepressant treatment, zinc, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
zinc + imipramine
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo + imipramine
Intervention Type
Dietary Supplement
Intervention Name(s)
Zincas Forte
Other Intervention Name(s)
Zincas Forte (Farmapol, Poland), Imipramin (Polfarma, Poland)
Intervention Description
25 mgZn/day + imipramine (100-200mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Imipramin (Polfarma, Poland)
Intervention Description
placebo + imipramine (100-200mg/day)
Primary Outcome Measure Information:
Title
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
To assess unwanted side effects in both groups
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrzej Zieba, Prof.
Organizational Affiliation
Department of Psychiatry, Collegium Medicum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Collegium Medicum, Jagiellonian University
City
Krakow
ZIP/Postal Code
31-501
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
14730113
Citation
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.
Results Reference
background

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Zinc Supplementation of Imipramine Therapy

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