Table 3.
Primary and secondary outcome measure findings.
| Measure | Baseline |
2-Week |
6-Month |
|||
|---|---|---|---|---|---|---|
| N | Mean (SD) | N | Mean (SD) | N | Mean (SD) | |
| Duration from baseline, weeks | 39 | - | 28 | 3.1 (1.5) | 27 | 29.0 (3.1) |
| Range | - | (1.9-7.0) | (19.7 - 35.1) | |||
| Mood Ratings | ||||||
| MADRS | 39 | 18.2 (12.4) | 28 | 11.8 (8.3) | 27 | 11.9 (9.5) |
| YMRS | 38 | 10.1 (9.5) | 28 | 8.5 (9.4) | 26 | 4.2 (4.9) |
| Vascular Assessment | ||||||
| Flow-mediated dilation (%) | 34 | 8.0 (3.9) | 23 | 8.4 (5.1) | 17 | 9.1 (4.3) |
| Nitroglycerine-mediated dilation (%) | 34 | 14.2 (3.7) | 23 | 13.4 (4.3) | 17 | 15.8 (6.5) |
| Pulse wave velocity (m/s) | 33 | 6.8 (1.2) | 26 | 6.9 (1.4) | 24 | 7.0 (1.0) |
| Aortic systolic pressure (mmHg) | 34 | 105.5 (11.8) | 25 | 103.1 (9.9) | 25 | 104.2 (10.1) |
| Augmentation pressure (mmHg) | 34 | 2.4 (6.7) | 25 | 2.0 (5.4) | 25 | 3.3 (4.5) |
| AIX@75 (mmHg) | 34 | 2.7 (16.7) | 25 | 1.4 (15.8) | 25 | 3.3 (14.1) |
| FVR acetylcholine 30 μg/min response (%) | 25 | 474.4 (330.3) | 16 | 342.1 (191.3) | 15 | 378.0 (226.4) |
| FVR nitroprusside 10 μg/min response (%) | 25 | 449.4 (213.8) | 15 | 365.1 (138.8) | 15 | 424.0 (252.2) |
| FVR verapamil 100 μg/min response (%) | 23 | 410.6 (221.0) | 15 | 312.9 (124.1) | 13 | 262.1 (121.5) |
| Vital Signs and Labs | ||||||
| Systolic blood pressure (mmHg) | 39 | 120.6 (11.0) | 28 | 117.8 (10.3) | 27 | 117.8 (10.6) |
| Diastolic blood pressure (mmHg) | 39 | 75.0 (10.6) | 28 | 71.4 (9.1) | 27 | 72.2 (10.3) |
| Mean arterial pressure (mmHg) | 39 | 87.8 (17.3) | 28 | 86.8 (8.6) | 27 | 87.4 (9.6) |
| Pulse pressures (mmHg) | 39 | 44.8 (11.5) | 28 | 46.5 (8.5) | 27 | 45.6 (8.4) |
| Heart rate (beats per minute) | 39 | 74.4 (11.3) | 28 | 77.2 (12.9) | 27 | 71.8 (12.4) |
| HOMA-IR* | 37 | 2.1 (1.3) | 27 | 3.2 (3.0) | 21 | 2.9 (2.5) |
| C-reactive protein (mg/L) | 35 | 2.6 (4.9) | 24 | 4.0 (8.5) | 21 | 2.4 (3.5) |
| Triglycerides (mg/dl) | 36 | 132.6 (107.0) | 26 | 135.1 (79.3) | 25 | 149.2 (60.7) |
| LDL-c (mg/dl) | 36 | 97.1 (31.1) | 26 | 103.8 (31.2) | 26 | 107.5 (36.7) |
| HDL-c (mg/dl) | 36 | 45.7 (14.2) | 26 | 46.7 (13.1) | 26 | 45.2 (13.7) |
*
HOMA-IR is used to assess β- cell function and insulin resistance using fasting glucose and insulin concentrations.
MADRS = Montgomery-Åsberg Depression Rating scale; YMRS = Young Mania Rating Scale; AIX@75 = augmentation index adjusted for heart rate of 75; FVR = forearm vascular resistance; HOMA-IR = homeostatic model assessment for insulin resistance; LDL-c = low density lipoprotein-cholesterol; HDL-c =high density lipoprotein-cholesterol