LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601002
• Other study ID #: HSREB-102574
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2012
• Last updated: April 20, 2016
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Weight Gain

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in weight as measured in the clinic		Weeks 1,2,4,8 and 12 weeks	No
Secondary	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)	No
Secondary	Proportion of patients achieving remission at end of study on HAM-D 24 (<11)		Start to end of study (12 weeks)	No
Secondary	Frequency of adverse events		Start to end of study (12 weeks)	No
Secondary	Percentage adhering to medication		Start to end of study (12 weeks)	No