Colorectal CancerPhase 3NCT00387348

Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer

A Phase 3 study testing escitalopram oxalate in people with Colorectal Cancer and Depression, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Escitalopram may help improve depression and quality of life in patients with advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with advanced lung or gastrointestinal cancer. Read more about this study

Who is it for?: Ages 35 to 85 years
Conditions the study is for: Colorectal Cancer, Depression, Esophageal Cancer
What is being tested?: escitalopram oxalate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Apr 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

DISEASE CHARACTERISTICS:

Diagnosis of any of the following for at least 4 weeks:
Stage IIIB (with effusions) or stage IV non-small cell lung cancer
Extensive stage small cell lung cancer
Stage III or IV pancreatic cancer
Stage IV liver cancer
Stage III or IV gallbladder cancer
Stage III or IV bile duct cancer
Stage IV esophageal cancer
Stage IV gastric cancer
Second line stage IV colorectal cancer
Meets diagnostic and Statistical Manual of Mental Disorders-4th Edition and Endicott criteria for major depressive disorder
Duration of depressive symptoms ≥ 4 weeks
Hamilton Depression D 17 (HAM-D 17) Scale ≥ 14
No active suicidality requiring immediate care or psychiatric hospitalization

PATIENT CHARACTERISTICS:

Able to swallow pills
No active substance abuse disorder (including alcohol abuse within the past 6 months), psychotic disorder or active psychotic symptoms, organic mental disorders, or bipolar disorder
No clinical or laboratory evidence of hypothyroidism
No hypercalcemia
No severe anemia, defined as hemoglobin < 10 g/dL
No history of multiple adverse drug reactions or allergy to study drugs
Not pregnant
No history of head trauma
No history of epilepsy

PRIOR CONCURRENT THERAPY:

No other concurrent antidepressant medications or psychostimulants

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Symptom Management Trial in Cancer Survivors

PURPOSE: This randomized clinical trial is studying the side effects of escitalopram and to see how well it works compared to a placebo in treating depression in patients with advanced lung or gastrointestinal cancer.

Read the detailed description

OBJECTIVES:

Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with advanced lung or gastrointestinal cancer.
Compare the side effect burden of escitalopram oxalate vs placebo in these patients.
Determine potential moderators of the efficacy of escitalopram oxalate in these patients, including medical, psychological, and social variables.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to stage of disease (stage IIIB with effusions vs stage IV) and current treatment (radiation vs chemotherapy vs novel agent). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral placebo once daily for 4 weeks followed by oral placebo once daily for another 4 weeks
Arm II: Patients receive oral placebo once daily for 4 weeks followed by escitalopram oxalate 10 mg once daily for 4 weeks.
Arm III: Patients receive oral escitalopram oxalate 10 mg once daily for 4 weeks followed by oral placebo once daily for 4 weeks.

After 8 weeks, all non-responders are offered open treatment with an antidepressant.

Depression, fatigue, quality of life, anxiety, and somatization are assessed at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Conditions: Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Fatigue, Gallbladder Cancer
Being tested: escitalopram oxalate, Placebo
Keywords: fatigue, psychosocial effects of cancer and its treatment, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, advanced adult primary liver cancer, depression, stage III pancreatic cancer, stage IV pancreatic cancer, stage IV esophageal cancer, stage IV gastric cancer, stage IVA colon cancer, stage IVB colon cancer, stage IVA rectal cancer, stage IVB rectal cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer
Medical subject headings: Colorectal Neoplasms, Depression, Esophageal Neoplasms, Bile Duct Neoplasms, Fatigue, Gallbladder Neoplasms, Stomach Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

escitalopram oxalateDrug
escitalopram oxalate 10 mg once daily for 4 weeks
PlaceboDrug
one placebo pill identical in appearance to the escitalpram pill once daily

Study groups in NCT00387348
Study group	Role	What they receive
Placebo-Placebo	Placebo comparator	Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks Receives: Drug: Placebo
Placebo-Escitalopram	Other	Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks Receives: Drug: escitalopram oxalate; Drug: Placebo
Escitalopram-Placebo	Other	Participants in this arm were randomzied to receive escitalopram 10 mg once daily for the first 4 weeks and placebo once daily for the second 4 weeks Receives: Drug: escitalopram oxalate; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.
Measured: 4 weeks
Change in Hamilton Depression Rating Scale (HAM-D) Scores
The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.
Measured: 4 weeks

Secondary outcomes (1)

Side Effect Burden
Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Apr 2011

First posted13 Oct 2006 (estimated)
Study startMar 2006
Primary completionApr 2011
Study completionApr 2011

Why it stopped: DSMB stopped study because placebo arm had more adverse events

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00387348
Sponsor's protocol ID: CDR0000505774
Other IDs: MGH-2006-P-000299, K23CA115908
Status last verified: Nov 2012
First submitted: 12 Oct 2006
Last updated: 3 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Symptom Management Trial in Cancer Survivors
ClinicalTrials.gov ID: NCT00387348
Acronym / sponsor ID: CDR0000505774
Conditions: Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Fatigue, Gallbladder Cancer
Keywords: fatigue, psychosocial effects of cancer and its treatment, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, advanced adult primary liver cancer, depression, stage III pancreatic cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: DSMB stopped study because placebo arm had more adverse events
Enrolment: 24 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Mar 2006
Primary completion: Apr 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 13 Oct 2006 (estimated)
Results: Posted 3 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with advanced lung or gastrointestinal cancer.
Compare the side effect burden of escitalopram oxalate vs placebo in these patients.
Determine potential moderators of the efficacy of escitalopram oxalate in these patients, including medical, psychological, and social variables.

Arm I: Patients receive oral placebo once daily for 4 weeks followed by oral placebo once daily for another 4 weeks
Arm II: Patients receive oral placebo once daily for 4 weeks followed by escitalopram oxalate 10 mg once daily for 4 weeks.
Arm III: Patients receive oral escitalopram oxalate 10 mg once daily for 4 weeks followed by oral placebo once daily for 4 weeks.

After 8 weeks, all non-responders are offered open treatment with an antidepressant.

Depression, fatigue, quality of life, anxiety, and somatization are assessed at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo-Placebo	Placebo comparator	Drug: PlaceboParticipants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks
Placebo-Escitalopram	Other	Drug: escitalopram oxalate, Drug: PlaceboParticipants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks
Escitalopram-Placebo	Other	Drug: escitalopram oxalate, Drug: PlaceboParticipants in this arm were randomzied to receive escitalopram 10 mg once daily for the first 4 weeks and placebo once daily for the second 4 weeks

Who may qualify

Ages: 35 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
escitalopram oxalateescitalopram oxalate 10 mg once daily for 4 weeks	Drug	Escitalopram-Placebo, Placebo-Escitalopram
Placeboone placebo pill identical in appearance to the escitalpram pill once daily	Drug	Escitalopram-Placebo, Placebo-Escitalopram, Placebo-Placebo

Primary outcome

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Time frame: 4 weeks
Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.
Change in Hamilton Depression Rating Scale (HAM-D) Scores
Time frame: 4 weeks
The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.

1 secondary outcome

Side Effect Burden
Time frame: 4 weeks

Results and safety

Results posted to the registry on 3 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo-Placebo	8	5
Placebo-Escitalopram	5	2
Escitalopram-Placebo	11	7

Primary outcome: Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder

Time frame: 4 weeks. Number. Unit: number of participants with response

Measure	Placebo-Placebo n = 8	Placebo-Escitalopram n = 5	Escitalopram-Placebo n = 11
Value	3 (0.52)	1 (0.47)	6 (0.52)

Population analysed: The efficacy analysis was intent to treat and all randomized participants were analyzed

Primary outcome: Change in Hamilton Depression Rating Scale (HAM-D) Scores

Time frame: 4 weeks. Mean (Standard Deviation). Unit: Change in HAM-D scores

Measure	Placebo-Placebo n = 7	Placebo-Escitalopram n = 5	Escitalopram-Placebo n = 11
Value	6.23 (8.37)	10.60 (5.18)	6.45 (5.18)

Population analysed: Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo-Placebo	1 of 8 (12.5%)	1 of 8 (12.5%)	Not reported
Placebo-Escitalopram	1 of 5 (20%)	0 of 5 (0%)	Not reported
Escitalopram-Placebo	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Limitations and caveats (from the sponsor): After an interim analaysis, the DSMB decided to terminate the trial early because of the rate of adverse events (HAM-D scores increasing by at least 25%) and deaths were higher in participants receiving placebo.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William F. Pirl, MD study chair

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing escitalopram oxalate in people with Colorectal Cancer and Depression, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00387348.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2012.