Major DepressionNCT00693680
Zinc Supplementation of Imipramine Therapy
A study testing Zincas Forte in people with Major Depression, run by Polish Academy of Sciences at 1 site in Poland.
Trial summary
Examination of the effect of zinc supplementation on imipramine therapy in major depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Zincas Forte
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2005to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
- one week washout period without any pharmacotherapy
Who cannot join
- psychotic symptoms
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Psychiatry, Collegium Medicum, Jagiellonian University
Krakow, 31-501
About this study
Official title: The Role of Zinc in Therapy of Unipolar Depression
Examination of the effect of zinc supplementation on imipramine therapy in major depression.
Read the 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.
- Conditions
- Major Depression
- Being tested
- Zincas Forte, Placebo
- Keywords
- depression, antidepressant treatment, zinc, placebo
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zincas ForteDietary supplement
Also called Zincas Forte (Farmapol, Poland), Imipramin (Polfarma, Poland)
25 mgZn/day + imipramine (100-200mg/day)
PlaceboDietary supplement
Also called Imipramin (Polfarma, Poland)
placebo + imipramine (100-200mg/day)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | zinc + imipramine Receives: Dietary Supplement: Zincas Forte |
| 2 | Placebo comparator | placebo + imipramine Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)
Measured: 12 weeks
Secondary outcomes (1)
To assess unwanted side effects in both groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University
- Investigators
- Andrzej Zieba, Prof., Principal investigator, Department of Psychiatry, Collegium Medicum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693680
- Sponsor's protocol ID
- ZnIMI/2004
- Status last verified
- Jun 2008
- First submitted
- 5 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 14730113
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Zinc in Therapy of Unipolar Depression
- ClinicalTrials.gov ID
- NCT00693680
- Acronym / sponsor ID
- ZnIMI/2004
- Conditions
- Major Depression
- Keywords
- depression, antidepressant treatment, zinc, placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- Jagiellonian University
- Study start
- Jan 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Zincas Fortezinc + imipramine |
| 2 | Placebo comparator | Dietary Supplement: Placeboplacebo + imipramine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with fulfilled DSM-IV criteria for moderate or severe depressive episode
- one week washout period without any pharmacotherapy
Key exclusion criteria (1 listed)
- psychotic symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zincas ForteAlso: Zincas Forte (Farmapol, Poland), Imipramin (Polfarma, Poland)25 mgZn/day + imipramine (100-200mg/day) | Dietary supplement | 1 |
| PlaceboAlso: Imipramin (Polfarma, Poland)placebo + imipramine (100-200mg/day) | Dietary supplement | 2 |
Primary outcome
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS)
Time frame: 12 weeks
1 secondary outcome
To assess unwanted side effects in both groups
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
- Background: PubMed 14730113Nowak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrzej Zieba, Prof. principal investigator
Department of Psychiatry, Collegium Medicum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zincas Forte in people with Major Depression, run by Polish Academy of Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the effect of zinc vs placebo in imipramine treated depressed patients (CGI, BDI, HADRS, MADRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2008.