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

NCT00387348 | Terminated Phase 3 Results DMC

• 3 other identifiers: CDR0000505774MGH-2006-P-000299K23CA115908
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic 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; 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks

Secondary Outcomes (1)

• Side Effect Burden

  4 weeks

Study Arms (3)

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

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

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

Drug: escitalopram oxalate; Drug: Placebo

Interventions

escitalopram oxalate DRUG

escitalopram oxalate 10 mg once daily for 4 weeks

Escitalopram-Placebo; Placebo-Escitalopram

Placebo DRUG

one placebo pill identical in appearance to the escitalpram pill once daily

Escitalopram-Placebo; Placebo-Escitalopram; Placebo-Placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Depression; Esophageal Neoplasms; Bile Duct Neoplasms; Fatigue; Gallbladder Neoplasms; Stomach Neoplasms; Liver Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Rectal Neoplasms

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavioral Symptoms; Behavior; Head and Neck Neoplasms; Esophageal Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gallbladder Diseases; Stomach Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: William F Pirl, MD
• Organization: Massachusetts General Hospital

wpirl@partners.org

617-724-9151

Study Officials

• William F. Pirl, MD

  Massachusetts General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2006
• First Posted: October 13, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 3, 2012
• Results First Posted: December 3, 2012

Record last verified: 2012-11

Locations

US (1)