Table 2.
In-trial patient outcomes for drinking and depression, expressed as percentage of patients or means
| Patients (N=170) | Sertraline + Naltrexone |
Naltrexone | Sertraline | Placebo | Sertraline + Naltrexone group vs. other groups combined |
|||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
P rimary Outcomes - Drinking and Depression |
% or M |
N | SD |
% or M |
N | SD |
% or M |
N | SD |
% or M |
N | SD |
χ2 or t |
p |
Odds Ratio or Cohen's d |
95% CI |
| Total Abstinence in Tx (% patients) |
53.7% (n=41) |
22 | 21.3% (n=47) |
10 | 27.5% (n=40) |
11 | 23.1% (n=39) |
9 | 12.9 | 0.001 | OR = 3.7 | 1.8 – 7.8 | ||||
| Time (days) to Relapse to Heavy Drinking (≥5 drinks/drink day--men; ≥4 drinks/drink day--women) |
Md=98 63.6 (n=41) |
40.8 | Md=29 45.2 (n=47) |
38.9 | Md=23 39.9 (n=40) |
38.3 | Md=26 41.7 (n=39) |
38.0 | 3.0 | 0.003 | d = 0.54 | .19 – .89 | ||||
| Not Depressed at Tx End (% patients w/Hamilton depression rating ≤ 9 in Last 3 Tx Weeks) |
83.3% (n=30) |
25 | 68.8% (n=32) |
22 | 48.1% (n=27) |
13 | 56% (n=25) |
14 | 6.1 | 0.014 | OR = 3.6 | 1.2 – 10.2 | ||||
| Hamilton Rating of Depression at Tx End |
6.9 (n=27) |
6.1 | 8 (n=29) |
7.0 | 11.7 (n=26) |
7.3 | 10.2 (n=21) |
8.0 | 2.1 | 0.042 | d = 0.44 | .02 – .87 | ||||
M = Mean; SD = Standard Deviation; CI = Confidence Interval; Tx = Treatment; OR = Odds Ratio; Md = Median; d = Cohen's statistic