LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

NCT01601002 | Completed Phase 4

• 1 other identifier: HSREB-102574
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Mirtazapine

Outcome Measures

Primary Outcomes (1)

• increase in weight as measured in the clinic

  Weeks 1,2,4,8 and 12 weeks

Secondary Outcomes (4)

• 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)

Study Arms (1)

Mirtazapine

EXPERIMENTAL

Mirtazapine in dosage of 7.5 mg to 45 mg/day

Drug: Mirtazapine

Interventions

Mirtazapine DRUG

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

Also known as: Remeron

Mirtazapine

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Akshya Vasudev, MBBS, MD, MRCPsych

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 17, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2016

Record last verified: 2016-04

Locations

CA (1)