LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Phase 4

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Mirtazapine

• Registration Number: NCT01601002
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-16
• Study First Posted: 2012-05-17
• Study Start: 2012-06
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mirtazapine	Mirtazapine	Mirtazapine in dosage of 7.5 mg to 45 mg/day

Primary Outcome Measures

Name	Time	Method
increase in weight as measured in the clinic	Weeks 1,2,4,8 and 12 weeks

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada