NCT01160380 · OUTCOME

Hospital Anxiety and Depression Scale (HADS) Score

A Study of the Effectiveness of Armodafinil to Treat Cancer-Related Fatigue in Patients With Multiple Myeloma · Source last updated 2014-11-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: units on a scale
Interval / dispersion: Standard Error
Time frame: Day 1, Day 28 and Day 56

What was measured

Survey used to assess depression and anxiety. The test consists of 14 items (7 for anxiety and 7 for depression); there are 4 possible answers for each statement. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores= more anxiety or depression.

Groups in this outcome

Armodafinil

The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily.

Placebo-First

These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Armodafinil	25
Placebo-First	25

Reported measurements

Anxiety-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	13.4	21.4	Not reported	Not reported	Not reported
Placebo-First	8.3	2.9	Not reported	Not reported	Not reported

Depression-Day 1 (n=18, 23)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	7.8	2.7	Not reported	Not reported	Not reported
Placebo-First	7.6	3.2	Not reported	Not reported	Not reported

Anxiety-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	6.9	4.6	Not reported	Not reported	Not reported
Placebo-First	5.5	3.3	Not reported	Not reported	Not reported

Depression-Day 28 (n=19, 23)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	10.3	17.8	Not reported	Not reported	Not reported
Placebo-First	6.6	3.6	Not reported	Not reported	Not reported

Anxiety-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	7.0	3.4	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Depression-Day 56 (n=15)

Values in units on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Armodafinil	5.7	2.9	Not reported	Not reported	Not reported
Placebo-First	NA	NA	Not reported	Not reported	Day 56 data was only evaluated for the Armodafinil arm

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment- HADS anxiety
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.945
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment- HADS depression
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.316
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.315
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.933
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.378
statistical Method
t-test, 2 sided
tested Non Inferiority
false

Complete source fields

analyses

ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment- HADS anxiety
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.945
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Comparison between arms at Day 28 of treatment- HADS depression
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.316
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS anxiety
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
group Ids
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.005
statistical Method
t-test, 2 sided
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Armodafinil arm-HADS anxiety
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.001
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 1 vs. Day 28 of treatment for the Placebo-First arm-HADS depression
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.315
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS anxiety
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.933
statistical Method
Wilcoxon (Mann-Whitney)
tested Non Inferiority
false
ci Num Sides
TWO_SIDED
group Description
Day 28 vs. Day 56 of treatment for the Armodafinil arm-HADS depression
group Ids
OG000
non Inferiority Type
SUPERIORITY_OR_OTHER
p Value
0.378
statistical Method
t-test, 2 sided
tested Non Inferiority
false

classes

categories
measurements
group Id
OG000
spread
21.4
value
13.4
group Id
OG001
spread
2.9
value
8.3
title
Anxiety-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
2.7
value
7.8
group Id
OG001
spread
3.2
value
7.6
title
Depression-Day 1 (n=18, 23)
categories
measurements
group Id
OG000
spread
4.6
value
6.9
group Id
OG001
spread
3.3
value
5.5
title
Anxiety-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
17.8
value
10.3
group Id
OG001
spread
3.6
value
6.6
title
Depression-Day 28 (n=19, 23)
categories
measurements
group Id
OG000
spread
3.4
value
7.0
comment
Day 56 data was only evaluated for the Armodafinil arm
group Id
OG001
spread
NA
value
NA
title
Anxiety-Day 56 (n=15)
categories
measurements
group Id
OG000
spread
2.9
value
5.7
comment
Day 56 data was only evaluated for the Armodafinil arm
group Id
OG001
spread
NA
value
NA
title
Depression-Day 56 (n=15)

denoms

counts
group Id
OG000
value
25
group Id
OG001
value
25
units
Participants

description

dispersion Type

Standard Error

groups

description
The patients receive armodafinil for all 56 days of the study. Armodafinil taken orally at 150 mg daily.
id
OG000
title
Armodafinil
description
These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56). Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.
id
OG001
title
Placebo-First

param Type

MEAN

reporting Status

POSTED

time Frame

Day 1, Day 28 and Day 56

title

Hospital Anxiety and Depression Scale (HADS) Score

type

SECONDARY

unit Of Measure

units on a scale

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Preserved source evidence · Not medical advice