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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01323205 | Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia | PHASE2 | COMPLETED | 100 | — | — | May 1, 2011 | Dec 1, 2012 | May 30, 2014 | 20 | Austria, Belgium +4 |
| Arm | Type | Description |
|---|---|---|
| JNJ-40411813 (Part A) | EXPERIMENTAL | JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks. |
| JNJ-40411813 (Part B) | EXPERIMENTAL | JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks. |
| Placebo and JNJ-40411813 (Part B) | EXPERIMENTAL | Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks. |
| Name | Type | Description |
|---|---|---|
| JNJ-40411813 | DRUG | JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks. |
| Placebo | DRUG | Placebo capsule (s) orally twice daily with a meal for 4 weeks. |
| Antipsychotic medication | DRUG | Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B. |
Inclusion Criteria: * Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive * Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests * In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and ...