LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Lawson Health Research Institute

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01601002

HSREB-102574

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

19 participants in 1 patient group

Mirtazapine

Experimental group

Description:

Mirtazapine in dosage of 7.5 mg to 45 mg/day

Treatment:

Drug: Mirtazapine