NCT00387348 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE3
Status at capture: TERMINATED
Registry last update: 2012-12-03

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

Side Effect Burden

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
maximum Age: 85 Years
minimum Age: 35 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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
intervention Names
Drug: Placebo
label
Placebo-Placebo
type
PLACEBO_COMPARATOR
description
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
intervention Names
Drug: escitalopram oxalate
Drug: Placebo
label
Placebo-Escitalopram
type
OTHER
description
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
intervention Names
Drug: escitalopram oxalate
Drug: Placebo
label
Escitalopram-Placebo
type
OTHER

interventions

arm Group Labels
Escitalopram-Placebo
Placebo-Escitalopram
description
escitalopram oxalate 10 mg once daily for 4 weeks
name
escitalopram oxalate
type
DRUG
arm Group Labels
Escitalopram-Placebo
Placebo-Escitalopram
Placebo-Placebo
description
one placebo pill identical in appearance to the escitalpram pill once daily
name
Placebo
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: TRIPLE
who Masked: PARTICIPANT
CARE_PROVIDER
INVESTIGATOR

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 24
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
time Frame
4 weeks
description
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.
measure
Change in Hamilton Depression Rating Scale (HAM-D) Scores
time Frame
4 weeks

secondary Outcomes

description
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.
measure
Side Effect Burden
time Frame
4 weeks

Full study description

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.
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.

Source references

Source notices and limitations

Discovery and provenance

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source url
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Preserved source evidence · Not medical advice