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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
Greater than or equal to 5% unintentional weight loss over the previous 3-6 months, not explained by simple starvation (Simple starvation is considered to be excluded when weight loss is not ameliorated by standard nutritional counseling and oral supplementation over a 2-week period)
Patients on Dexamethasone will be allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is comparing olanzapine to mirtazapine to see which is more effective in preventing weight loss and appetite loss in cancer patients.

Eligible Conditions
  • Anorexia Nervosa

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have lost more than 5% of your body weight over the last 3-6 months without trying to lose weight. This is not due to just not eating, and has not improved with standard nutrition advice and supplements for at least 2 weeks.
Select...
You can still participate even if you are taking Dexamethasone.
Select...
You are expected to live for at least 4 more months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Weight
Secondary outcome measures
Quality of Life of patient

Side effects data

From 2008 Phase 4 trial • 25 Patients • NCT00001656
31%
Increased appetite
31%
Hypersalivation
17%
tachycardia >100 beats/min (supine)
15%
Somnolence
15%
Constipation
9%
Hypertension
8%
Difficulty concentrating
8%
Enuresis
8%
Insomnia
8%
Abnormal white blood count
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olanzapine Group
Clozapine Group

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
19 Previous Clinical Trials
478 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions does Olanzapine commonly help to alleviate?

"Olanzapine is not only used to treat post traumatic stress disorder (PTSD), but also panic attacks, major depressive disorder (MDD), and acute agitation."

Answered by AI

What is the United States Federal Drug Administration's opinion on Olanzapine?

"While Phase 2 trials don't have the same amount of data supporting efficacy, there is enough information to suggest that Olanzapine is safe."

Answered by AI

What other trials are similar to this one?

"Zyprexa (olanzapine) was first studied in 2007 by Eli Lilly and Company. 20 patients were involved in the initial clinical trial which ultimately led to drug approval. 28 active studies are currently ongoing across 11 countries and 407 cities."

Answered by AI

Are there any current openings for individuals in this trial?

"The clinical trial in question is no longer recruiting patients, as indicated by the website clinicaltrials.gov. This particular study was first posted on 1/20/2022 and updated for the last time on 7/25/2022. However, 419 other trials are still looking for patients to enroll."

Answered by AI

Are there other scientific investigations that have included Olanzapine in their research?

"Olanzapine is being trialed in 28 different ongoing clinical studies, 7 of which are Phase 3 trials. The majority of the locations for these trials are based in Wheat Ridge, Colorado; however, there are a total of 738 sites running Olanzapine trials."

Answered by AI

How many test subjects are involved in this research project?

"This trial is no longer looking for new patients to enroll. It was originally posted on 1/20/2022, with the most recent edit on 7/25/2022. However, there are other clinical trials - 391 related to anorexia and 28 involving Olanzapine - that are still recruiting participants."

Answered by AI
~54 spots leftby Mar 2025