Zinc Supplementation of Imipramine Therapy

Not Applicable

Completed

• Conditions: Major Depression
• Interventions: Dietary Supplement: Zincas Forte; Dietary Supplement: Placebo

• Registration Number: NCT00693680
• Lead Sponsor: Polish Academy of Sciences

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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-06
• Study First Posted: 2008-06-09
• Last Update Submitted: 2008-06-09
• Last Update Posted: 2008-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
• one week washout period without any pharmacotherapy

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Exclusion Criteria

• psychotic symptoms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zincas Forte	zinc + imipramine
2	Placebo	placebo + imipramine

Primary Outcome Measures

Name	Time	Method
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)	12 weeks

Secondary Outcome Measures

Name	Time	Method
To assess unwanted side effects in both groups	12 weeks

Trial Locations

Locations (1)

Department of Psychiatry, Collegium Medicum, Jagiellonian University; 🇵🇱 Krakow, Poland