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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
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.
Eligible Conditions
- Anorexia Nervosa
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 • NCT0000165670%
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
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken Marinol within two weeks before joining the study.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.You can still participate even if you are taking Dexamethasone.You are expected to live for at least 4 more months.
Research Study Groups:
This trial has the following groups:- Group 1: Olanzapine
- Group 2: Mirtazapine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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