Table 3. Adverse Events Elicited During the Trial by Treatment Group.
| Adverse Eventa | No. (%) | P Valueb | |
|---|---|---|---|
|
| |||
| Citalopram Hydrobromide–Treated Group (n=73) | Placebo Group (n=76) | ||
| Any adverse event | 71 (97.3) | 66 (86.8) | .03 |
|
| |||
| Neuropsychiatric Disorders | |||
| Energy level increased | 28 (38.4) | 15 (19.7) | .02 |
| Anger or irritability | 18 (24.7) | 13 (17.1) | .31 |
| Aggression or hostility | 17 (23.3) | 13 (17.1) | .42 |
| Headache or migraine | 15 (20.5) | 10 (13.2) | .28 |
| Restlessness or difficulty settling down | 13 (17.8) | 7 (9.2) | .15 |
| Disinhibited, impulsive, or intrusive behavior | 14 (19.2) | 5 (6.6) | .03 |
| Silliness | 9 (12.3) | 10 (13.2) | >.99 |
| Anxiety | 8 (11.0) | 9 (11.8) | >.99 |
| Mood lability | 7 (9.6) | 9 (11.8) | .79 |
| Increased speech | 8 (11.0) | 4 (5.3) | .24 |
| Attention and concentration decreased | 9 (12.3) | 2 (2.6) | .03 |
| Hyperactivity | 9 (12.3) | 2 (2.6) | .03 |
| Stereotypy | 8 (11.0) | 1 (1.3) | .02 |
|
| |||
| Gastrointestinal Disorders | |||
| Diarrhea or loose stools | 19 (26.0) | 9 (11.8) | .04 |
| Abdominal discomfort | 13 (17.8) | 9 (11.8) | .36 |
| Vomiting or nausea | 14 (19.2) | 6 (7.9) | .06 |
|
| |||
| Sleep Disturbance | |||
| Any insomnia | 28 (38.4) | 17 (22.4) | .05 |
| Insomnia, initial or difficulty falling asleep | 17 (23.3) | 7 (9.2) | .03 |
| Insomnia, midcycle or other | 13 (17.8) | 9 (11.8) | .36 |
|
| |||
| Infections and Infestations | |||
| Cold, flu, or other systemic infection | 31 (42.5) | 26 (34.2) | .32 |
|
| |||
| Metabolism and Nutrition Disorders | |||
| Appetite decreased | 11 (15.1) | 10 (13.2) | .82 |
| Appetite increased | 7 (9.6) | 8 (10.5) | >.99 |
|
| |||
| Skin and Subcutaneous Tissue Disorders | |||
| Rash | 12 (16.4) | 8 (10.5) | .34 |
| Other skin or subcutaneous tissue disorder | 9 (12.3) | 1 (1.3) | .01 |
|
| |||
| General Disorders | |||
| Fatigue | 10 (13.7) | 10 (13.2) | >.99 |
|
| |||
| Immune System Disorders | |||
| Allergies | 15 (20.5) | 11 (14.5) | .39 |
|
| |||
| Respiratory, Thoracic, and Mediastinal Disorders | |||
| Cough | 10 (13.7) | 5 (6.6) | .18 |
|
| |||
| Serious Events | |||
| Any serious adverse event | 1 (1.4) | 0 | .49 |
a
Adverse events with at least 10% occurrence in 1 or both groups, excluding adverse events present at baseline.
b
Italics indicate statistical significance.