Trial Outcomes & Findings for Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment (NCT NCT00536172)
NCT ID: NCT00536172
Last Updated: 2023-09-21
Results Overview
Number of participants reaching pre-defined threshold on the QIDS-SR-16 of \>/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
160 participants
Primary outcome timeframe
Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28
Results posted on
2023-09-21
Participant Flow
298 patients were screened for possible study eligibility from January 6, 2008, to December 28, 2011. 160 subjects agreed to participate.
12 of the 160 subjects who agreed to participate were not eligible: 9 QIDS or QIDS-C \>/=11; 1 not able/willing to return for follow-up; 1 received antidepressants in the past week; 1 not diagnosed with epidermoid cancer and meets MINI criteria for depression. The remaining 148 subjects were randomized.
Participant milestones
| Measure |
Escitalopram
Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
|
Placebo
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
COMPLETED
|
60
|
65
|
|
Overall Study
NOT COMPLETED
|
14
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Effectiveness of Escitalopram to Prevent Depression in Head and Neck Cancer Patients Receiving Treatment
Baseline characteristics by cohort
| Measure |
Escitalopram
n=74 Participants
Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
|
Placebo
n=74 Participants
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
32 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
118 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
62.8 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
63.0 years
STANDARD_DEVIATION 11.9 • n=27 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
85 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=93 Participants
|
71 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
145 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
74 participants
n=93 Participants
|
74 participants
n=4 Participants
|
148 participants
n=27 Participants
|
|
Clinical Stage
II
|
17 participants
n=93 Participants
|
18 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Clinical Stage
III/IV
|
57 participants
n=93 Participants
|
56 participants
n=4 Participants
|
113 participants
n=27 Participants
|
|
Cancer Site
oral
|
29 participants
n=93 Participants
|
36 participants
n=4 Participants
|
65 participants
n=27 Participants
|
|
Cancer Site
pharynx
|
25 participants
n=93 Participants
|
24 participants
n=4 Participants
|
49 participants
n=27 Participants
|
|
Cancer Site
skin
|
9 participants
n=93 Participants
|
8 participants
n=4 Participants
|
17 participants
n=27 Participants
|
|
Cancer Site
salivary gland
|
6 participants
n=93 Participants
|
5 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Cancer Site
sinus
|
5 participants
n=93 Participants
|
1 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Cancer Type
squamous cell
|
65 participants
n=93 Participants
|
67 participants
n=4 Participants
|
132 participants
n=27 Participants
|
|
Cancer Type
salivary gland
|
5 participants
n=93 Participants
|
5 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Cancer Type
skin
|
4 participants
n=93 Participants
|
0 participants
n=4 Participants
|
4 participants
n=27 Participants
|
|
Cancer Type
missing
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Initial Treatment Type (Surgery or Radiation)
surgery, not biopsy
|
42 participants
n=93 Participants
|
39 participants
n=4 Participants
|
81 participants
n=27 Participants
|
|
Initial Treatment Type (Surgery or Radiation)
radiation with/without chemotherapy
|
32 participants
n=93 Participants
|
35 participants
n=4 Participants
|
67 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28Population: Evaluable subjects
Number of participants reaching pre-defined threshold on the QIDS-SR-16 of \>/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression.
Outcome measures
| Measure |
Escitalopram
n=60 Participants
Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
|
Placebo
n=65 Participants
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
|---|---|---|
|
Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)
|
6 participants
|
16 participants
|
Adverse Events
Escitalopram
Serious events: 16 serious events
Other events: 47 other events
Deaths: 16 deaths
Placebo
Serious events: 13 serious events
Other events: 49 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Escitalopram
n=74 participants at risk
Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
|
Placebo
n=74 participants at risk
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and vomiting
|
2.7%
2/74 • Number of events 3 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Nervous system disorders
Confusion
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Dehydration
|
5.4%
4/74 • Number of events 5 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Cardiac disorders
Atrial Fibrillation
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Fever
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Pain
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Musculoskeletal and connective tissue disorders
Fractured Leg
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Renal and urinary disorders
Acute Renal Failure
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Dizziness/Syncope/Fall
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Gastrointestinal disorders
GI Bleed
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Nervous system disorders
Mental Status Change
|
2.7%
2/74 • Number of events 2 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Infections and infestations
Wound Infection
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Cardiac disorders
Coronary Stenosis
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
G-tube Procedure Monitoring
|
1.4%
1/74 • Number of events 1 • 16 weeks of blinded and 12 weeks of open-label treatment
|
0.00%
0/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
Other adverse events
| Measure |
Escitalopram
n=74 participants at risk
Participants will receive treatment with escitalopram
Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks.
|
Placebo
n=74 participants at risk
Participants will receive treatment with placebo
Placebo: Placebo distribution matches the active medication.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
8.1%
6/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
5.4%
4/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Insomnia
|
13.5%
10/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
17.6%
13/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Mucositis
|
12.2%
9/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
18.9%
14/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
General disorders
Nausea and vomiting
|
21.6%
16/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
10.8%
8/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
1/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
9.5%
7/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
|
Infections and infestations
Upper Respiratory Infection
|
6.8%
5/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
4.1%
3/74 • 16 weeks of blinded and 12 weeks of open-label treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place