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Zinc Supplementation of Imipramine Therapy

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ClinicalTrials.gov Identifier: NCT00693680
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : June 13, 2008
Sponsor:
Collaborator:
Jagiellonian University
Information provided by:
Polish Academy of Sciences

Study Description
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Brief Summary:
Examination of the effect of zinc supplementation on imipramine therapy in major depression.

Condition or disease Intervention/treatment Phase
Major Depression Dietary Supplement: Zincas Forte Dietary Supplement: Placebo Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Zinc in Therapy of Unipolar Depression
Study Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. To assess unwanted side effects in both groups [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693680


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

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Responsible Party: prof. Gabriel Nowak, Institute of Pharmacology, Polish Academy of Sciences
ClinicalTrials.gov Identifier: NCT00693680    
Other Study ID Numbers: ZnIMI/2004
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: June 2008
Keywords provided by Polish Academy of Sciences:
depression
antidepressant treatment
zinc
placebo
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Imipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
 Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs