Zinc Supplementation of Imipramine Therapy

Polish Academy of Sciences60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Major Depression

Interventions

Zincas ForteDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

placebo + imipramine (100-200mg/day)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry, Collegium Medicum, Jagiellonian University

Krakow, Poland

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

To assess unwanted side effects in both groups

Time frame: 12 weeks

Data from ClinicalTrials.gov

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