Zinc Supplementation of Imipramine Therapy

The Role of Zinc in Therapy of Unipolar Depression

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00693680

Enrollment

Registered

2008-06-09

Start date

2005-01-31

Completion date

2006-04-30

Last updated

2008-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression

Keywords

depression, antidepressant treatment, zinc, placebo

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.

Interventions

DIETARY_SUPPLEMENTZincas Forte

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

DIETARY_SUPPLEMENTPlacebo

placebo + imipramine (100-200mg/day)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To assess unwanted side effects in both groups	12 weeks

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026