LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01601002
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : April 21, 2016
Information provided by (Responsible Party):
Akshya Vasudev, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Mirtazapine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?
Study Start Date : June 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Mirtazapine
U.S. FDA Resources

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 Name: Remeron

Primary Outcome Measures :
  1. increase in weight as measured in the clinic [ Time Frame: Weeks 1,2,4,8 and 12 weeks ]

Secondary Outcome Measures :
  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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01601002

Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Lawson Health Research Institute
Principal Investigator: Akshya Vasudev, MBBS, MD, MRCPsych Lawson Health Research Institute

Responsible Party: Akshya Vasudev, Principal Investigator, Lawson Health Research Institute Identifier: NCT01601002     History of Changes
Other Study ID Numbers: HSREB-102574
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Akshya Vasudev, Lawson Health Research Institute:

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