TABLE 3.
Adverse Events Reported in ≥5% of Patients in Any Group
| Adverse Event | Phases 1 and 2: Open-Label (%) |
Phase 3: Double-Blind (%) |
||
|---|---|---|---|---|
| Citalopram Monotherapy |
Risperidone Augmentation |
Placebo Augmentation |
Risperidone Augmentation |
|
| N | 110 | 93 | 31 | 32 |
| Headache | 18.2 | 5.4 | 0 | 9.4 |
| Insomnia | 10.0 | 5.4 | 3.2 | 3.1 |
| Diarrhea | 10.0 | 4.3 | 6.5 | 0 |
| Nausea | 9.1 | 5.4 | 3.2 | 3.1 |
| Somnolence | 8.2 | 4.3 | 3.2 | 3.1 |
| Dizziness | 6.4 | 9.7 | 6.5 | 6.3 |
| Dry mouth | 5.5 | 9.7 | 6.5 | 3.1 |
| URTI | 4.5 | 1.1 | 6.5 | 6.3 |
| Constipation | 2.7 | 5.4 | 6.5 | 3.1 |
| Fatigue | 2.7 | 1.1 | 6.5 | 3.1 |
| Weight increase | 2.7 | 2.2 | 6.5 | 6.3 |
| Pruritus | 2.7 | 2.2 | 0 | 6.3 |
| Nasopharyngitis | 1.8 | 5.4 | 0 | 0 |
| Fall | 1.8 | 0 | 0 | 6.3 |
| Anxiety | 0.9 | 5.4 | 0 | 0 |
| Lethargy | 0.9 | 0 | 6.5 | 0 |
| Seasonal allergy | 0.9 | 0 | 6.5 | 0 |
| Appetite increase | 0 | 3.2 | 3.2 | 6.3 |
| Dyspepsia | 0 | 2.2 | 0 | 6.3 |
| Joint stiffness | 0 | 5.4 | ||
| Peripheral swelling | 0 | 0 | 0 | 6.3 |
| Sensation of heaviness | 0 | 0 | 0 | 6.3 |