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?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01601002

Enrollment

Registered

2012-05-17

Start date

2012-06-30

Completion date

2015-12-31

Last updated

2016-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Mirtazapine

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.

Interventions

DRUGMirtazapine

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026