Table 3.
Variable | Combination Therapy (N=140) | Sertraline (N=133) | Cognitive Behavioral Therapy (N=139) | Placebo (N=76) |
---|---|---|---|---|
number (percent) | ||||
Withdrawal from treatment | 1 (0.7) | 7 (5.3) | 0 | 3 (3.9) |
Attributed to an adverse event | 1 (0.7) | 2 (1.5) | 0 | 2 (2.6) |
Tremor | 0 | 1 (0.8) | 0 | 0 |
Stomach pain | 0 | 1 (0.8) | 0 | 0 |
Suicidal ideation | 0 | 0 | 0 | 1 (1.3) |
Worsening symptoms | 1 (0.7) | 0 | 0 | 1 (1.3) |
Other reason | 0 | 5 (3.8) | 0 | 1 (1.3) |
Improved symptoms | 0 | 0 | 0 | 1 (1.3) |
Declined treatment | 0 | 5 (3.8) | 0 | 0 |
Withdrawal from study | 12 (8.6) | 16 (12.0) | 6 (4.3) | 12 (15.8) |
Attributed to an adverse event | 2 (1.4) | 6 (4.5) | 0 | 1 (1.3) |
Agitation or disinhibition | 1 (0.7) | 2 (1.5) | 0 | 0 |
Self-harm or homicidal ideation | 0 | 1 (0.8) | 0 | 0 |
Hyperactivity | 0 | 1 (0.8) | 0 | 0 |
Worsening symptoms | 1 (0.7) | 1 (0.8) | 0 | 0 |
Headache | 0 | 1 (0.8) | 0 | 0 |
Rash | 0 | 0 | 0 | 1 (1.3) |
Other reason | 10 (7.1) | 10 (7.5) | 6 (4.3) | 11 (14.5) |
Lack of improvement | 2 (1.4) | 0 | 1 (0.7) | 1 (1.3) |
Loss of contact | 5 (3.6) | 3 (2.3) | 2 (1.4) | 2 (2.6) |
Time burden | 0 | 0 | 1 (0.7) | 1 (1.3) |
Withdrawal of consent | 3 (2.1) | 7 (5.3) | 1 (0.7) | 6 (7.9) |
Other | 0 | 0 | 1 (0.7) | 1 (1.3) |
Subjects who withdrew from treatment stopped receiving their assigned therapy but continued to undergo assessment; those who withdrew from the study stopped receiving their assigned treatment and did not undergo continued assessment.