lyoo_2012bis

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SUPPLEMENTAL DATA

Contents

APPENDIX SA1. Reliability for measurements

FIGURE SF1. Individual-level trajectories of changes in HDRS scores and their lines of best fit

during treatment period (A) and those for LOCF data (B)

FIGURE SF2. Proportions of responders and remitters after creatine monohydrate or placebo

augmentation of SSRI by HDRS (A) and MADRS (B) scores

TABLE ST1. Laboratory profiles of subjects with major depressive disorder randomly assigned

to creatine monohydrate or placebo augmentation of SSRI

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Appendix SA1. Reliability for measurements

All structured interviews including the Structured Clinical Interview for the DSM-IV, the 17-item

Hamilton Depression Rating Scale (HDRS), the Montgomery-Åsberg Depression Rating Scale

(MADRS), and the Clinical Global Impression Scale-severity-of-illness subscale were

conducted by an experienced board-certified psychiatrist (T.S.K). High inter-rater reliability for

the measurement was ensured between the rater (T.S.K) and another experienced board-

certified psychiatrist (J.H.) indicating mean intraclass correlation coefficients during the study

period for the total scores of the HDRS and the MADRS were 0.952 (standard deviation [SD],

0.027) and 0.939 (SD, 0.018), respectively. Quality control procedures for clinical assessmentswere conducted approximately every 6 months during the entire study period.

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Data Supp lement for Lyoo e t al . (doi: 10.1176/appi.ajp.2012.12010009)

Figure SF1. Individual-level trajectories of changes in HDRS scores and their lines of best fit during treatment period

0 1 2 3 4 5 6 7 8

0

10

20

30

40

0 1 2 3 4 5 6 7 8

0

10

20

30

40

Baseline Wk 1 Wk 2 Wk 4 Wk 8 Baseline Wk 1 Wk 2 Wk 4 Wk 8

Creatine augmentation Placebo augmentation

H D R S s c o r e s

H D R S s c o r e s

p for interaction 0.16 < 0.001 < 0.001 < 0.001

Individual observed changes in H5RS scores

Line of best fit

Individual observed changes in H5RS scores

Line of best fit

Changes in the HDRS scores during an 8-week of study period were analyzed by using the mixed-effects model repeated measures analys is for an intention-to-treat sample. Main effects for treatmentgroups and visits as well as their interaction terms were included into the model. Age and HDRS scores were also included as covariates into the model. Blue and gray dotted l ines in the figurescorrespond to the lines of best fit of these mixed-effects models for the creatine and the placebo groups, respectively. P values for treatment groups by each week interaction terms were depicted in thefigures..

Abbreviations: HDRS=Hamilton Depression Rating Scale, Wk=week.

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Figure SF2. Proport ions of responders and remitters after creatine monohydrate or placebo augmentation of SSRI by HDRS scores

1 2 3 4 5 6 71 2 3 4 5 6 7

0

20

40

60

80

100

S u b j e c t s ( %

)

Baseline Wk 1 Wk 2 Wk 4 Wk 8 Baseline Wk 1 Wk 2 Wk 4 Wk 8Wk 8 Wk 8

Creatine augmentation Placebo augmentation

Non

response

Non

response

Non

response

Non

remission

5ropout

5ropout

5ropout 5ropout

5ropout

RemissionResponse Response Response

N=8 N=17 N=16* N=13*

p=0.014 (OR=16.1)

p=0.001 (OR=16.5)

p=0.17 (OR=5.0)

p=0.008 (OR=6.9)

Non

remission

5ropout

5ropout

5ropout

5ropout

Non

response

Non

response

Non

response

Non

response

Non

response

Response Response Remission

N=8 N=17 N=7

P values and odds ratios were calculated using the logist ic regression modeling for the effects of treatment groups with outcome measures of the treatment response or non-response at each visit as wellas the remission or non-remission at week 8.*One patient, who was assigned to the creatine group and responded/remitt ed at week 4, discont inued the trial at week 8.

Abbreviations: SSRI=selective serotonin reuptake inhibitor; HDRS=Hamilton Depression Rating Scale; OR=odds ratio; Wk=week.

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Table ST1. Laboratory profiles of subjects with major depressive disorder randomly assigned tocreatine monohydrate or placebo augmentation of SSRI

Laboratory profiles Week

Creatine monohydrate

augmentation

Placebo

augmentation p value a N mean (SD) N mean (SD)

Serum creatinine, mg/dL Baseline 25 0.69 (0.08) 27 0.68 (0.10) 0.51Week 2 18 0.81 (0.11) 24 0.66 (0.12) <0.001Week 8 17 0.79 (0.15) 21c 0.67 (0.11) 0.01

Serum BUN, mg/dL Baseline 25 12.5 (2.9) 27 12.8 (4.3) 0.79Week 8 17 13.5 (2.7) 21c 12.9 (2.9) 0.51

AST, units/L d Baseline 25 21.4 (6.8) 27 21.0 (7.5) 0.83Week 8 17 23.6 (10.9) 21c 21.6 (5.8) 0.45

ALT, units/L d Baseline 25 19.9 (7.6) 27 21.0 (15.5) 0.75Week 8 17 23.5 (13.5) 21c 20.0 (8.5) 0.35

BMI, kg/m Baseline 25 24.2 (2.7) 27 23.1 (3.1) 0.18Week 8 17 24.2 (2.9) 22 22.8 (3.2) 0.18

a P values are calculated by the t statistics.b One patient of the creatine group did not examine serum creatinine levels at week 2.c One patient of the placebo group refused the laboratory tests at week 8.d Two patients in the creatine group (one patient, AST 47 units/L and ALT 47 units/L; the other patient, AST 49 units/L and ALT 57 units/L) and one in the placebo group (ALT 42 units/L) showed mildincrease in the levels of liver transaminases beyond the upper normal limit at week 8.Abbreviations: SSRI=selective serotonin reuptake inhibitor; SD=standard deviation; BUN=blood urea nitrogen; AST=aspartate aminotransferase; ALT=alanine aminotransferase; BMI=body mass index.

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