Skip to main content
OpenTrials
Completed

NCT Number: NCT01601002

LEPR Polymorphism Weight Gain by Mirtazapine in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mirtazapine

Drug

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

Other names: Remeron

Primary outcomes

  1. increase in weight as measured in the clinic

    Time frame: Weeks 1,2,4,8 and 12 weeks

Secondary outcomes

  1. Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores

    Time frame: Start to end of study (12 weeks)

  2. Proportion of patients achieving remission at end of study on HAM-D 24 (<11)

    Time frame: Start to end of study (12 weeks)

  3. Frequency of adverse events

    Time frame: Start to end of study (12 weeks)

  4. Percentage adhering to medication

    Time frame: Start to end of study (12 weeks)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 17, 2012
Registry last updated
Apr 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.