Table 4.
Outcome measures 0–20 weeks.
Endpoints | Lovastatin group (n = 11) | Minocycline group (n = 10) | Both groups (n = 21) | ||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | 20 weeks | p | Baseline | 20 weeks | p | Baseline | 20 weeks | p | |
ABC-CFX | |||||||||
Global score | 48 (35–58) | 33 (24–40) | 0.054 | 41 (26–65) | 24 (16–53) | 0.143 | 48 (27–62) | 29 (16–45) | 0.004 |
Irritability | 8 (3–10) | 3 (1–9) | 0.412 | 6.5 (1–14) | 3 (1–9) | 0.617 | 8 (3–11) | 3 (1–10) | 0.306 |
Lethargy | 8 (6–14) | 7 (3–8) | 0.129 | 10.5 (6–14) | 5.5 (1–11) | 0.009 | 10 (5–14) | 6 (2–9) | 0.005 |
Stereotypy | 6 (4–10) | 5 (4–6) | 0.191 | 5 (3–6) | 4.5 (2–5) | 0.375 | 5 (3–10) | 5 (3–5) | 0.111 |
Hyperactivity | 7 (4–9) | 3 (2–7) | 0.014 | 5.5 (4–10) | 4 (2–7) | 0.262 | 6 (4–9) | 3 (2–7) | 0.006 |
Inappropriate speech | 5 (4–7) | 5 (3–6) | 0.176 | 6.5 (4–8) | 3.5 (2–8) | 0.103 | 5 (4–5) | 4 (2–4) | 0.028 |
Social avoidance | 8 (7–11) | 5 (4–8) | 0.027 | 5.5 (4–8) | 4.5 (2–8) | 0.406 | 7 (5–10) | 5 (4–8) | 0.020 |
ADAMS | |||||||||
Total score | 28 (17–40) | 23 (16–29) | 0.043 | 30 (14–49) | 16 (10–37) | 0.082 | 28 (17–40) | 19 (12–29) | 0.008 |
Manic/hyperactive behavior | 5 (3–6) | 3 (3–6) | 0.169 | 6 (3–9) | 4.5 (2–6) | 0.152 | 5 (3–7) | 4 (2–6) | 0.047 |
Depressed mood | 3 (1–4) | 1 (1–4) | 0.177 | 4.5 (1–10) | 3.5 (1–6) | 0.586 | 3 (1–6) | 2 (1–4) | 0.202 |
Social avoidance | 11 (8–15) | 8 (6–11) | 0.076 | 8 (6–17) | 5.5 (4–11) | 0.056 | 9 (6–15) | 7 (5–12) | 0.007 |
General anxiety | 5 (3–13) | 4 (3–8) | 0.063 | 6.5 (4–10) | 3 (0–8) | 0.078 | 6 (3–11) | 3 (1–8) | 0.008 |
Obsessive/compulsive behavior | 2 (2–3) | 2 (1–4) | 0.440 | 4 (1–5) | 1 (0–3) | 0.172 | 2 (1–4) | 2 (0–3) | 0.074 |
BRIEF | |||||||||
Inhibit | 24 (20–28) | 21 (19–26) | 0.005 | 22.5 (19–27) | 20.5 (17–23) | 0.021 | 23 (20–27) | 21 (17–23) | <0.001 |
Shift | 23 (20–25) | 19 (18–21) | 0.010 | 20 (18–23) | 18 (17–21) | 0.042 | 21 (19–24) | 19 (17–21) | 0.001 |
Emotion control | 17 (15–20) | 15 (14–19) | 0.018 | 14.5 (13–18) | 13 (12–17) | 0.513 | 16 (14–19) | 15 (12–18) | 0.043 |
Monitor | 10 (9–12) | 10 (9–11) | 0.703 | 10.5 (8–13) | 9 (7–12) | 0.096 | 10 (8–12) | 9 (8–11) | 0.124 |
Working memory | 24 (22–27) | 23 (22–24) | 0.092 | 21.5 (20–25) | 21 (20–23) | 0.181 | 22 (20–25) | 22 (20–23) | 0.026 |
Organize materials | 10.5 (8–13) | 9.5 (8–12) | 0.943 | 9 (7–11) | 9.5 (8–12) | 0.052 | 9 (7–11) | 9 (7–12) | 0.366 |
Task completion | 21 (18–22) | 18 (16–22) | 0.205 | 17.5 (15–19) | 15.5 (13–18) | 0.290 | 18 (15–19) | 16 (13–18) | 0.087 |
SRS | |||||||||
Total raw score | 163 (157–170) |
149 (139–159) |
<0.001 | 150 (130–174) |
135 (131–149) |
0.081 | 162 (138–171) |
146 (133–159) |
<0.001 |
Awareness | 19 (18–21) | 17 (17–21) | 0.632 | 19 (18–20) | 17 (16–19) | 0.078 | 19 (18–21) | 17 (16–19) | 0.097 |
Cognition | 30 (27–33) | 27 (25–32) | 0.003 | 30 (26–33) | 26.5 (26–28) | 0.305 | 30 (26–33) | 27 (25–29) | 0.015 |
Communication | 52 (50–58) | 49 (42–56) | 0.009 | 45.5 (44–54) | 44.5 (41–49) | 0.274 | 51 (44–57) | 47 (41–50) | 0.009 |
Motivation | 29 (27–31) | 25 (23–29) | 0.048 | 25 (23–29) | 23.5 (22–27) | 0.144 | 27 (24–30) | 25 (22–28) | 0.011 |
Mannerisms | 32 (28–34) | 27 (25–30) | 0.001 | 29 (23–35) | 24.5 (22–30) | 0.130 | 30 (26–34) | 26 (23–30) | 0.001 |
Data are presented as median (interquartile range). P value < 0,05 are in bold. ABC-CFX, aberrant behavior checklist-community adapted for FXS; ADAMS, anxiety, depression and mood scale; BRIEF-SR, behavior rating inventory of executive function-self-report version; SRS, social responsiveness scale.