Zinc Supplementation of Imipramine Therapy

Polish Academy of Sciences

Status: Completed

Conditions: Major Depression

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Zincas Forte

Study type: Interventional

Funder types: Other

Identifiers

NCT00693680

ZnIMI/2004

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

zinc + imipramine

Treatment:

Dietary Supplement: Zincas Forte

2

Placebo Comparator group

Description:

placebo + imipramine

Treatment:

Dietary Supplement: Placebo