LEPR Polymorphism Weight Gain by Mirtazapine in Late Life... | NCT01601002

Studies
LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

NCT01601002

Sponsor

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

Status

Completed

Last Update Posted

Apr 21, 2016Estimated

Enrollment

19Actual

Phase

Phase 4

Conditions

Major Depressive Disorder

Interventions

Mirtazapine

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

May 15, 2012

First Submission Date that Met QC Criteria

May 16, 2012

First Posted Date

May 17, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2016

Last Update Posted Date

Apr 21, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Akshya Vasudev, Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirtazapine	Experimental	Mirtazapine in dosage of 7.5 mg to 45 mg/day	Drug: Mirtazapine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirtazapine	Drug	Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label	Mirtazapine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
increase in weight as measured in the clinic		Weeks 1,2,4,8 and 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Akshya Vasudev, MBBS, MD, MRCPsych	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Centre		London	Ontario	N6A 5W9	Canada

ID	Term
D003865	Depressive Disorder, Major

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D000078785	Mirtazapine

Ancestor Terms

ID	Term
D003984	Dibenzazepines
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

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