Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01094249 | A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder | PHASE1 | COMPLETED | 9 | — | — | Feb 1, 2009 | Apr 1, 2009 | Apr 8, 2014 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | divalproex sodium ER/paliperidone ER Divalproex sodium ER (dose determined from the patients prescreening therapeutic dose) once daily from Day 1 through Day 7 and once daily in combination with paliperidone ER 12 mg from Day 8 through Day 12 |
| Name | Type | Description |
|---|---|---|
| divalproex sodium ER/paliperidone ER | DRUG | Divalproex sodium ER (dose determined from the patients prescreening therapeutic dose) once daily from Day 1 through Day 7 and once daily in combination with paliperidone ER 12 mg from Day 8 through Day 12 |
Inclusion Criteria: * Have a diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * Is clinically stable with no psychiatric hospitalization or change in existing mood stabilizers, antipsychotic, or an...