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Antidepressant

Olanzapine and Mirtazapine for Weight Loss in Advanced Stage Cancer

Phase 2
Waitlist Available
Research Sponsored by Englewood Hospital and Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing two medications, olanzapine and mirtazapine, to see which one helps cancer patients keep their weight and appetite. Cancer patients often lose weight and appetite, and these drugs might help by making them feel better emotionally and physically. Olanzapine and mirtazapine have been shown to improve appetite and reduce nausea in cancer patients, which can help with weight maintenance.

Who is the study for?
This trial is for adults with advanced cancer who have lost more than 5% of their weight unintentionally over the last 3-6 months, despite nutritional support. They must be able to consent, communicate effectively, and have a life expectancy of at least 4 months. Those on dexamethasone or undergoing chemotherapy can join. People using Marinol recently, with abnormal heart rhythms or liver function, or primarily fed intravenously cannot participate.
What is being tested?
The study aims to compare the effectiveness of two medications, Olanzapine and Mirtazapine, in preventing further weight loss and appetite loss in patients with advanced stage cancer. It will assess which drug better helps manage these symptoms associated with cancer.
What are the potential side effects?
Possible side effects from Olanzapine include drowsiness, increased appetite leading to weight gain, dry mouth, constipation and fatigue. Mirtazapine may cause similar side effects such as sleepiness, elevated hunger resulting in potential weight gain along with dry mouth.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Weight
Secondary study objectives
Quality of Life of patient

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656
70%
tachycardia >100 beats/min (supine)
67%
Hypersalivation
64%
Hypertension
42%
Enuresis
33%
Increased appetite
33%
Difficulty concentrating
25%
Insomnia
17%
Abnormal white blood count
17%
Somnolence
17%
Constipation
10%
Tachycardia >120 beats/min (supine)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clozapine Group
Olanzapine Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: OlanzapineExperimental Treatment1 Intervention
Group II: MirtazapineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
2012
Completed Phase 4
~409200
Olanzapine
2005
Completed Phase 4
~5480

Find a Location

Who is running the clinical trial?

Englewood Hospital and Medical CenterLead Sponsor
20 Previous Clinical Trials
603 Total Patients Enrolled

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05170919 — Phase 2
Anorexia nervosa Research Study Groups: Olanzapine, Mirtazapine
Anorexia nervosa Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT05170919 — Phase 2
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05170919 — Phase 2
~67 spots leftby Dec 2026
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