LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's19 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

MirtazapineDRUG

Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

increase in weight as measured in the clinic

Time frame: Weeks 1,2,4,8 and 12 weeks

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)

Data from ClinicalTrials.gov

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