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Can a common antidepressant help cancer patients eat better?

NCT ID NCT00488072

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether mirtazapine, a drug often used for depression, can improve appetite in people with advanced cancer who have lost weight and have little desire to eat. About 98 patients will receive either mirtazapine or a placebo for 29 days. Researchers will track changes in appetite, sleep, and other symptoms to see if the drug helps.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mirtazapine
What this could lead to
If it works, this could offer a way to improve appetite and quality of life for advanced cancer patients struggling with weight loss.
What could go wrong
This is a small, early-phase study with only 98 participants. The results may not apply to all cancer patients, and mirtazapine can cause side effects like drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

98 people

The number who actually took part.

Started

Jan 2007

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Patients \> 18 years of age 3. Karnofsky Performance score of \> 40 at time of inclusion into study 4. Ability to provide informed consent and comply with study procedures 5. Ability and willingness to return to engage in telephone follow-up by research nurse on days 2 (+/- 3 days), 8 (+/- 3 days), 16 ( +/- 3 days), and 22 (+/- 3 days) and return to outpatient clinic for evaluation on days 15 (+/- 3 days), and 29 (+/- 3 days). 6. Negative urine pregnancy test at time of inclusion into study for female patients of childbearing potential, within 24 hours of study enrollment. 7. For patients receiving chemotherapy eligibility to be determined after discussion with primary oncologist 8. Drowsiness of \</= 4/10 on ESAS at baseline due to known potential sedating effects of Mirtazapine 9. Patient can continue all medications including complementary therapies or antineoplastic therapy while on-study (with the permission of their Attending MD) if they have been on stable dose for at least 2 weeks. 10. Patients who are on stable doses of antidepressants for at least 2 months. Exclusion Criteria: 1. Patients who have known dementia or delirium at time of enrollment as determined by a physician. 2. Known hypersensitivity to any ingredient of Mirtazapine 3. Inability to maintain oral intake over the course of the study, such as with mechanical obstruction of the alimentary tract or intractable vomiting 4. Ongoing use of tube feeding or parenteral nutrition 5. Current use of corticosteroids (with the exception of scheduled doses during time of chemotherapy), dronabinol, testosterone and progesterone derivatives such as megestrol acetate, or in the preceding 1 week prior to study enrollment. 6. Pregnancy or lactation or unwillingness to use contraceptives 7. A score of 11 or more, in each subscale of the Hospital Anxiety and Depression scale (HADS) indicating clinical depression or anxiety. Those with HADS scores of \> 11 at baseline indicating moderate or severe depression will be excluded from the study and will be referred for appropriate follow up by counselor and psychiatry evaluation. 8. Patients on chronic use of benzodiazepines are excluded

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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