Zinc Supplementation of Imipramine Therapy

Major Depression Clinical Trial

Official title:

The Role of Zinc in Therapy of Unipolar Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693680
• Other study ID #: ZnIMI/2004
• Status: Completed
• Phase: N/A
• First received: June 5, 2008
• Last updated: June 9, 2008
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: June 2008
• Source: Polish Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Dietary Supplement:
• Zincas Forte
25 mgZn/day + imipramine (100-200mg/day)
• Placebo
placebo + imipramine (100-200mg/day)

Locations

Country	Name	City	State
Poland	Department of Psychiatry, Collegium Medicum, Jagiellonian University	Krakow

Sponsors (2)

Lead Sponsor	Collaborator
Polish Academy of Sciences	Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)		12 weeks	No
Secondary	To assess unwanted side effects in both groups		12 weeks	Yes