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
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
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
Start Date: June 2012
Completed Date: December 2015
Phase: Phase 4
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