LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Study Overview
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Brief Summary
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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.

Official Title
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Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Mirtazapine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirtazapine<br>Mirtazapine in dosage of 7.5 mg to 45 mg/day | Drug: Mirtazapine<br>* Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label<br>* Other names: Remeron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in weight as measured in the clinic |  | Weeks 1,2,4,8 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores |  | Start to end of study (12 weeks) | 
| Proportion of patients achieving remission at end of study on HAM-D 24 (<11) |  | Start to end of study (12 weeks) | 
| Frequency of adverse events |  | Start to end of study (12 weeks) | 
| Percentage adhering to medication |  | Start to end of study (12 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mirtazapine