Major Depressive Disorder | LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Major Depressive Disorder research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MirtazapineMirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MirtazapineMirtazapine in dosage of 7.5 mg to 45 mg/day

Study Status


Start Date: June 2012

Completed Date: December 2015

Phase: Phase 4

Type: Interventional


Primary Outcome: increase in weight as measured in the clinic

Secondary Outcome: Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores

Study sponsors, principal investigator, and references

Principal Investigator: Akshya Vasudev, MBBS, MD, MRCPsych

Lead Sponsor: Lawson Health Research Institute


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