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Antidepressant

Mirtazapine for Cancer-related Appetite Loss

Phase 2
Waitlist Available
Led By Shalini Dalal, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Advanced cancer patients seen in outpatient clinics or inpatient units at MD Anderson Cancer Center, with presence of anorexia for at least one month, and accompanied by weight loss of > 5 % of pre-illness body weight in the last 6 months. Anorexia on the day of enrollment (day 0 +/-3) must be > 4/10 on ESAS.
Karnofsky Performance score of > 40 at time of inclusion into study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)
Awards & highlights

Study Summary

This trial is testing whether Mirtazapine can help improve appetite, insomnia, and other symptoms in advanced cancer patients with anorexia and weight loss.

Who is the study for?
Adult cancer patients with anorexia and weight loss can join this trial. They must be able to consent, follow the study plan, and attend clinic visits. Pregnant women or those on certain medications like corticosteroids are excluded, as well as patients with dementia or severe depression/anxiety.Check my eligibility
What is being tested?
The trial is testing if Mirtazapine improves appetite in advanced cancer patients compared to a placebo. It also looks at sleep quality, pain relief, mood changes, and quality of life over about a month.See study design
What are the potential side effects?
Mirtazapine may cause drowsiness (which is why people already very sleepy can't join), increased appetite which could lead to weight gain, dry mouth, constipation or diarrhea. Some might feel dizzy or have abnormal dreams.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have advanced cancer, lost more than 5% of my weight in 6 months, and feel a strong lack of appetite.
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I can care for myself but may not be able to do active work.
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I have been on a stable dose of antidepressants for at least 2 months.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 15 ( +/- 3 days), and day 29 ( +/- 3 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 15 ( +/- 3 days), and day 29 ( +/- 3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Comparison of ESAS scores in Appetite
Secondary outcome measures
Insomnia (as measured by Pittsburgh Sleep Quality Index)

Side effects data

From 2014 Phase 4 trial • 38 Patients • NCT01178671
44%
nausea
43%
sexual dysfunction (men)
43%
decreased libido (men)
33%
fatigue
28%
somnolence
28%
dry mouth
28%
constipation
28%
decreased appetite
28%
sweating
28%
urinary dysfunction
28%
diarrhea
28%
tremor
27%
decreased libido (women)
22%
lightheadedness
22%
forgetfulness
22%
impaired concentration
18%
sexual dysfunction (women)
17%
apathy
17%
heartburn
17%
emesis
17%
headache
11%
incoordination
11%
blurry vision
11%
increased appetite
11%
insomnia
6%
nervousness
6%
skin problems
6%
bruising
6%
restlessness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sertraline and Sugar Pill
Sertraline and Mirtazapine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MirtazapineExperimental Treatment1 Intervention
Mirtazapine 15 mg by mouth (PO) daily for 15 days; Day 22-29, increased to 30 mg PO daily.
Group II: PlaceboPlacebo Group1 Intervention
One placebo tablet by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirtazapine
2012
Completed Phase 4
~409200

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,298 Total Patients Enrolled
6 Trials studying Weight Loss
311 Patients Enrolled for Weight Loss
Shalini Dalal, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Mirtazapine (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT00488072 — Phase 2
Weight Loss Research Study Groups: Placebo, Mirtazapine
Weight Loss Clinical Trial 2023: Mirtazapine Highlights & Side Effects. Trial Name: NCT00488072 — Phase 2
Mirtazapine (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00488072 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Mirtazapine on Appetite in Advanced Cancer Patients
2006. "Effects of Mirtazapine on Appetite in Advanced Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00488072.
All > Sleep Disorders > Weight Loss
~8 spots leftby Dec 2025
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