DepressionMIRPROTNCT01681407
Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications
An observational study of Depression, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in depressive patients, treated with SSRI medications. It is an observational clinical bio-markers laboratory controlled research with no device. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- How many people
- 17 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to Feb 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients at community or hospital settings. Patients were clinically evaluated for suspected depression.
Who may be able to join
- Depressed patients,over 18 yo
- Untreated with SSRI, in the last 3 months
Who cannot join
- Bipolar patients or another major psychopathology
- Depressive disorder clearly due to general medical condition, or drug related
- BMI under 18.5 or above 40
- Pregnant patients
- Active suicidality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.
A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in depressive patients, treated with SSRI medications. It is an observational clinical bio-markers laboratory controlled research with no device.
The research includes two groups; one for patients diagnosed of having depression, and will get a standard SSRI medication regimen. Second group is for control subjects without depression. An option for a third group is planned to include first degree relatives of the depressed patients. After giving their informed consents, subjects and patients will go through standard clinical psychiatric interview, and routine clinical lab tests. Clinical standard, specific depression and anxiety questionnaires will be held at four follow-up meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked to give blood samples at these points of time for the lab processing: Complete plasma proteomics and specific micro-RNA levels.
- Conditions
- Depression
- Keywords
- Depression, Selective Serotonin Reuptake Inhibitors, MicroRNAs, Proteome
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depressed Patients | Patients: Group of patients that are diagnosed for having depression, and are suitable for SSRI treatment. | |
| Non-Depressed Controls | Controls: Volunteers that had clinical screening with no depression diagnosis. | |
| Patients Relatives | Patient Relatives (Optional group for later stage): First degree relatives with no depression diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms remission or response rates, under usual SSRI treatment.
Measured: 10 weeks of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionFeb 2014
Why it stopped: Insufficient microRNA for the analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amichai Hareven, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681407
- Sponsor's protocol ID
- EMC-07411-CTIL
- Acronym
- MIRPROT
- Status last verified
- Jun 2015
- First submitted
- 5 Sep 2012
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Plasma Micro-RNA and Proteomics Mapping in Depressive Patients, Treated With SSRI Medications.
- ClinicalTrials.gov ID
- NCT01681407
- Acronym / sponsor ID
- MIRPROT / EMC-07411-CTIL
- Conditions
- Depression
- Keywords
- Depression, Selective Serotonin Reuptake Inhibitors, MicroRNAs, Proteome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient microRNA for the analysis
- Enrolment
- 17 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Sep 2012 (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.
A pilot study of mapping the peripheral plasma micro-RNA and proteomics patterns in depressive patients, treated with SSRI medications. It is an observational clinical bio-markers laboratory controlled research with no device.
The research includes two groups; one for patients diagnosed of having depression, and will get a standard SSRI medication regimen. Second group is for control subjects without depression. An option for a third group is planned to include first degree relatives of the depressed patients. After giving their informed consents, subjects and patients will go through standard clinical psychiatric interview, and routine clinical lab tests. Clinical standard, specific depression and anxiety questionnaires will be held at four follow-up meetings: at start; after 2 weeks; 4 weeks; and 10 weeks. Subjects and patients will be asked to give blood samples at these points of time for the lab processing: Complete plasma proteomics and specific micro-RNA levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depressed Patients | – | –Patients: Group of patients that are diagnosed for having depression, and are suitable for SSRI treatment. |
| Non-Depressed Controls | – | –Controls: Volunteers that had clinical screening with no depression diagnosis. |
| Patients Relatives | – | –Patient Relatives (Optional group for later stage): First degree relatives with no depression diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at community or hospital settings. Patients were clinically evaluated for suspected depression.
Key inclusion criteria (2 listed)
- Depressed patients,over 18 yo
- Untreated with SSRI, in the last 3 months
Key exclusion criteria (5 listed)
- Bipolar patients or another major psychopathology
- Depressive disorder clearly due to general medical condition, or drug related
- BMI under 18.5 or above 40
- Pregnant patients
- Active suicidality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depressive symptoms remission or response rates, under usual SSRI treatment.
Time frame: 10 weeks of follow up
Results and safety
The study was stopped early (reason given: Insufficient microRNA for the analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 5 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: stopped early, as of the sponsor's last update on 19 Jun 2015. 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 Israel. 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. 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 was stopped early (reason given: Insufficient microRNA for the analysis). Results are not available in the source record.
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?
Depressive symptoms remission or response rates, under usual SSRI treatment. (time frame: 10 weeks of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.