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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

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date June 13, 2008
Study Start Date  ICMJE January 2005
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2008)		 To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2008)		 To assess unwanted side effects in both groups [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc Supplementation of Imipramine Therapy
Official Title  ICMJE The Role of Zinc in Therapy of Unipolar Depression
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE
  • Dietary Supplement: Zincas Forte
    25 mgZn/day + imipramine (100-200mg/day)
    Other Names:
    • Zincas Forte (Farmapol, Poland)
    • Imipramin (Polfarma, Poland)
  • Dietary Supplement: Placebo
    placebo + imipramine (100-200mg/day)
    Other Name: Imipramin (Polfarma, Poland)
Study Arms  ICMJE
  • Active Comparator: 1
    zinc + imipramine
    Intervention: Dietary Supplement: Zincas Forte
  • Placebo Comparator: 2
    placebo + imipramine
    Intervention: Dietary Supplement: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 6, 2008)		 60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2006
Actual Primary Completion Date April 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693680
Other Study ID Numbers  ICMJE ZnIMI/2004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party prof. Gabriel Nowak, Institute of Pharmacology, Polish Academy of Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Polish Academy of Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Jagiellonian University
Investigators  ICMJE
Principal Investigator: Andrzej Zieba, Prof. Department of Psychiatry, Collegium Medicum
PRS Account Polish Academy of Sciences
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP