Table 2.
Adverse events in completers at baseline and week 8.
| Adverse event | Placebo group (N = 4) | Modafinil group (N = 6) | ||||
|---|---|---|---|---|---|---|
| BL | Wk8 | Notes | BL | Wk8 | Notes | |
| Diarrhea | 0 | 0 | – | 0 | 0 | – |
| Constipation | 0 | 0 | – | 0 | 0 | – |
| Dry mouth | 0 | 0 | – | 2 | 0 | Resolved since BL |
| Nausea/vomiting | 1 | 0 | Resolved since BL | 0 | 0 | – |
| Palpitations | 0 | 0 | – | 1 | 2 | N = 1 new since BL |
| Dizziness standing | 0 | 0 | – | 0 | 0 | – |
| Chest pain | 0 | 0 | – | 0 | 0 | – |
| Rash | 0 | 0 | – | 0 | 0 | – |
| Increased perspiration | 0 | 0 | – | 0 | 0 | – |
| Itching | 0 | 0 | – | 0 | 1 | N = 1 new since BL |
| Dry skin | 1 | 0 | Resolved since BL | 1 | 0 | Resolved since BL |
| Headache | 2 | 0 | Resolved since BL | 1 | 0 | Resolved since BL |
| Tremors | 0 | 0 | – | 0 | 0 | – |
| Poor coordination | 0 | 0 | – | 1 | 0 | Resolved since BL |
| Dizziness | 0 | 0 | – | 0 | 0 | – |
| Blurred vision | 0 | 0 | – | 0 | 0 | – |
| Ringing ears | 0 | 0 | – | 0 | 0 | – |
| Difficulty urinating | 0 | 0 | – | 0 | 0 | – |
| Painful urination | 0 | 0 | – | 0 | 0 | – |
| Frequent urination | 0 | 1 | New since BL | 1 | 0 | Resolved since BL |
| Menstrual irregularity | 0 | 0 | – | 0 | 0 | – |
| Difficulty sleeping | 2 | 2 |
N = 1 resolved since BL N = 1 new since BL |
3 | 2 |
N = 1 resolved since BL N = 0 new since BL |
| Sleeping too much | 0 | 0 | – | 0 | 0 | – |
| Loss of sexual desire | 0 | 0 | – | 0 | 0 | – |
| Trouble with orgasm | 0 | 0 | – | 0 | 0 | – |
| Trouble with erections | 0 | 0 | – | 0 | 0 | – |
| Anxiety | 1 | 0 | Resolved since BL | 0 | 0 | – |
| Poor concentration | 2 | 1 |
N = 2 resolved since BL N = 1 new since BL |
3 | 0 | Resolved since BL |
| General malaise | 0 | 0 | – | 0 | 0 | – |
| Restlessness | 1 | 0 | Resolved since BL | 0 | 0 | – |
| Fatigue | 3 | 0 | Resolved since BL | 2 | 2 |
N = 1 resolved since BL N = 1 new since BL |
| Decreased energy | 3 | 1 |
N = 2 resolved since BL N = 0 new since BL |
0 | 2 | N = 2 new since BL |
| Other | 0 | 0 | – | 0 | 0 | – |
| Suicidal ideation | 2 | 0 | Resolved since BL | 2 | 0 | Resolved since BL |
| Suicidal behavior | 1* | 0 | Resolved since BL | 0 | 0 | – |
| Suicide attempt | 1 | 0 | Resolved since BL | 1 | 0 | Resolved since BL |
BL, baseline; * = participant reported non-suicidal self-injurious behavior at baseline.