LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Lawson Health Research Institute
Sponsor:
Information provided by (Responsible Party):
Akshya Vasudev, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01601002
First received: May 15, 2012
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Drug: Mirtazapine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • increase in weight as measured in the clinic [ Time Frame: Weeks 1,2,4,8 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Proportion of patients achieving remission at end of study on HAM-D 24 (<11) [ Time Frame: Start to end of study (12 weeks) ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: Start to end of study (12 weeks) ] [ Designated as safety issue: No ]
  • Percentage adhering to medication [ Time Frame: Start to end of study (12 weeks) ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Remeron

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601002

Contacts
Contact: Akshya Vasudev, MBBS,MD,MRCPsych 5196858500 ext 76693 akshya.vasudev@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Akshya Vasudev, MD    5196676693    akshya.vasudev@lhsc.on.ca   
Principal Investigator: Akshya Vasudev, MBBS, MD, MRCPsych         
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Akshya Vasudev, MBBS, MD, MRCPsych Lawson Health Research Institute
  More Information

No publications provided

Responsible Party: Akshya Vasudev, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01601002     History of Changes
Other Study ID Numbers: HSREB-102574
Study First Received: May 15, 2012
Last Updated: February 25, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Mirtazapine

Additional relevant MeSH terms:
Body Weight Changes
Depression
Depressive Disorder
Depressive Disorder, Major
Weight Gain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Body Weight
Signs and Symptoms
Mirtazapine
Mianserin
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on July 28, 2014