LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Mirtazapine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirtazapine; Mirtazapine in dosage of 7.5 mg to 45 mg/day	Drug: Mirtazapine; Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label; Other Names: Remeron

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Akshya Vasudev, MBBS, MD, MRCPsych, Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 16, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Estimate): April 21, 2016
• Last Update Submitted That Met QC Criteria: April 20, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Mirtazapine
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Body Weight; Body Weight Changes; Depressive Disorder; Depressive Disorder, Major; Weight Gain; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Adrenergic alpha-Antagonists; Adrenergic alpha-2 Receptor Antagonists; Mirtazapine
• Other Study ID Numbers: HSREB-102574