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Zinc Supplementation of Imipramine Therapy

This study has been completed.
Sponsor:
Collaborator:
Jagiellonian University
Information provided by:
Polish Academy of Sciences
ClinicalTrials.gov Identifier:
NCT00693680
First received: June 5, 2008
Last updated: June 9, 2008
Last verified: June 2008
History of Changes
  Purpose

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


Condition Intervention
Major Depression
 Dietary Supplement: Zincas Forte
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Zinc in Therapy of Unipolar Depression

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Polish Academy of Sciences:

Primary Outcome Measures:
  • To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess unwanted side effects in both groups [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: January 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
zinc + imipramine
 Dietary Supplement: Zincas Forte
25 mgZn/day + imipramine (100-200mg/day)
Other Names:
  • Zincas Forte (Farmapol, Poland)
  • Imipramin (Polfarma, Poland)
Placebo Comparator: 2
placebo + imipramine
 Dietary Supplement: Placebo
placebo + imipramine (100-200mg/day)
Other Name: Imipramin (Polfarma, Poland)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693680

Locations
Poland
Department of Psychiatry, Collegium Medicum, Jagiellonian University
Krakow, Poland, 31-501
Sponsors and Collaborators
Polish Academy of Sciences
Jagiellonian University
Investigators
Principal Investigator: Andrzej Zieba, Prof. Department of Psychiatry, Collegium Medicum
  More Information

Publications:

Responsible Party: prof. Gabriel Nowak, Institute of Pharmacology, Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT00693680     History of Changes
Other Study ID Numbers: ZnIMI/2004
Study First Received: June 5, 2008
Last Updated: June 9, 2008
Health Authority: Poland: Ministry of Health

Keywords provided by Polish Academy of Sciences:
depression
antidepressant treatment
zinc
placebo

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Imipramine
Zinc
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013