Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
This study has been terminated.
(DSMB stopped study because placebo arm had more adverse events)
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
William Pirl, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00387348
First received: October 12, 2006
Last updated: November 2, 2012
Last verified: November 2012
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Purpose
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.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Depression Esophageal Cancer Extrahepatic Bile Duct Cancer Fatigue Gallbladder Cancer Gastric Cancer Liver Cancer Lung Cancer Pancreatic Cancer |
Drug: escitalopram oxalate Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Symptom Management Trial in Cancer Survivors |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Colorectal Cancer
Depression
Esophageal Cancer
Esophagus Disorders
Fatigue
Liver Cancer
Lung Cancer
Pancreatic Cancer
Stomach Cancer
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Side Effect Burden [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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.
| Enrollment: | 24 |
| Study Start Date: | March 2006 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo-Placebo
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
|
Drug: Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
|
|
Placebo-Escitalopram
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
|
Drug: escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
Drug: Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
|
|
Escitalopram-Placebo
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
|
Drug: escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
Drug: Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387348
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Study Chair: | William F. Pirl, MD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | William Pirl, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00387348 History of Changes |
| Other Study ID Numbers: | CDR0000505774, MGH-2006-P-000299, K23CA115908 |
| Study First Received: | October 12, 2006 |
| Results First Received: | July 12, 2012 |
| Last Updated: | November 2, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Massachusetts General Hospital:
|
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 |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Depression Depressive Disorder Esophageal Diseases Esophageal Neoplasms Fatigue Liver Neoplasms Lung Neoplasms Stomach Neoplasms Pancreatic Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Gastrointestinal Neoplasms Intestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Behavioral Symptoms Mood Disorders Mental Disorders Head and Neck Neoplasms Signs and Symptoms Liver Diseases Respiratory Tract Neoplasms Thoracic Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013