NCT00387348 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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

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primary · POSTED

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.

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.

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secondary · POSTED

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.

Participants who completed the 4 week assessment were analyzed

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-gallbladder-cancer-locally-advanced-f92cb583
nct id: NCT00387348
trial label: Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
applicability: unclear
applicability note: Attached because the study's own record describes locally advanced disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0000
source section id
NCT00387348-om-0000
source outcome index
0
endpoint
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
endpoint definition
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.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis was intent to treat and all randomized participants were analyzed
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0002
source section id
NCT00387348-om-0002
source outcome index
2
endpoint
Change in Hamilton Depression Rating Scale (HAM-D) Scores
endpoint definition
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.
time origin
4 weeks
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0001
source section id
NCT00387348-om-0001
source outcome index
1
endpoint
Side Effect Burden
endpoint definition
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.
time origin
4 weeks
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants who completed the 4 week assessment were analyzed
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0000
arm key
OG000
arm label
Placebo-Placebo
regimen
Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
analyzed count
8
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0000
arm key
OG001
arm label
Placebo-Escitalopram
regimen
Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0000
arm key
OG002
arm label
Escitalopram-Placebo
regimen
Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0001
arm key
OG000
arm label
Placebo-Placebo
regimen
Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0001
arm key
OG001
arm label
Placebo-Escitalopram
regimen
Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0001
arm key
OG002
arm label
Escitalopram-Placebo
regimen
Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
analyzed count
9
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0002
arm key
OG000
arm label
Placebo-Placebo
regimen
Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
analyzed count
7
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0002
arm key
OG001
arm label
Placebo-Escitalopram
regimen
Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
outcome key
om-0002
arm key
OG002
arm label
Escitalopram-Placebo
regimen
Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
analyzed count
11
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00387348-om-0002#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
harm key
EG000
source section id
NCT00387348-ae
event group key
EG000
event group label
Placebo-Placebo
serious affected
1
serious at risk
8
other affected
1
other at risk
8
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
harm key
EG001
source section id
NCT00387348-ae
event group key
EG001
event group label
Placebo-Escitalopram
serious affected
1
serious at risk
5
other affected
0
other at risk
5
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-gallbladder-cancer-locally-advanced-f92cb583
nct id
NCT00387348
harm key
EG002
source section id
NCT00387348-ae
event group key
EG002
event group label
Escitalopram-Placebo
serious affected
0
serious at risk
11
other affected
1
other at risk
11
frequency threshold
5
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice