Major Depressive DisorderPhase 4NCT01601002
LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression
A Phase 4 study testing Mirtazapine in people with Major Depressive Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mirtazapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to Dec 2015
- Phase
- Phase 4
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients older than 50 years
- meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score > 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist
Who cannot join
- Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)
- Major depressive disorder with psychosis (296.x4)
- Those with depression who fulfill the chronic specifier (MDE for >2 years)
- Significant Axis II pathology
- Previous trial with mirtazapine
- Concurrent antipsychotic usage
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- Comorbid dementia (as confirmed by MMSE < 24)
- Substance misuse including drug and/or alcohol dependence/abuse in the past 3 months
- Bipolar disorder
- Schizophrenia
- Obsessive compulsive disorder
- Post traumatic stress disorder
- Eating disorder
- Head injury
- Recent stroke (< 3 months)
- Recent MI (< 3 months)
- Currently actively participating in structured/formal psychotherapy
- Being non ambulatory
- Those actively suicidal
- Those incapable of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?
Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain.
- Conditions
- Major Depressive Disorder
- Being tested
- Mirtazapine
- Keywords
- Mirtazapine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called Remeron
Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Experimental | Mirtazapine in dosage of 7.5 mg to 45 mg/day Receives: Drug: Mirtazapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in weight as measured in the clinic
Measured: Weeks 1,2,4,8 and 12 weeks
Secondary outcomes (4)
Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores
Measured: Start to end of study (12 weeks)
Proportion of patients achieving remission at end of study on HAM-D 24 (<11)
Measured: Start to end of study (12 weeks)
Frequency of adverse events
Measured: Start to end of study (12 weeks)
Percentage adhering to medication
Measured: Start to end of study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akshya Vasudev, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Akshya Vasudev, MBBS, MD, MRCPsych, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601002
- Sponsor's protocol ID
- HSREB-102574
- Status last verified
- Apr 2016
- First submitted
- 15 May 2012
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?
- ClinicalTrials.gov ID
- NCT01601002
- Acronym / sponsor ID
- HSREB-102574
- Conditions
- Major Depressive Disorder
- Keywords
- Mirtazapine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 May 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.
Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Experimental | Drug: MirtazapineMirtazapine in dosage of 7.5 mg to 45 mg/day |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients older than 50 years
- meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score > 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist
Key exclusion criteria (20 listed)
- Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)
- Major depressive disorder with psychosis (296.x4)
- Those with depression who fulfill the chronic specifier (MDE for >2 years)
- Significant Axis II pathology
- Previous trial with mirtazapine
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 |
|---|---|---|
| MirtazapineAlso: RemeronMirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label | Drug | Mirtazapine |
Primary outcome
increase in weight as measured in the clinic
Time frame: Weeks 1,2,4,8 and 12 weeks
4 secondary outcomes
Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores
Time frame: Start to end of study (12 weeks)
Proportion of patients achieving remission at end of study on HAM-D 24 (<11)
Time frame: Start to end of study (12 weeks)
Frequency of adverse events
Time frame: Start to end of study (12 weeks)
Percentage adhering to medication
Time frame: Start to end of study (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 21 Apr 2016.
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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.
Akshya Vasudev, MBBS, MD, MRCPsych principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirtazapine in people with Major Depressive Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 20 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 21 Apr 2016. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
increase in weight as measured in the clinic (time frame: Weeks 1,2,4,8 and 12 weeks). 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 21 Apr 2016.