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JNJ-37822681 · 2 trials · 1 indication
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
The AIMS rates the severity of involuntary movements from 0 (none) to 4 (severe), including facial and oral movements, extremity movements, trunk movements, global and judgments, and 2 additional items concerning dental status (yes/no). A total score (ranging from 0 to 28) will be calculated as the sum of items 1 to 7.
The BARS includes an objective rating, 2 subjective ratings of symptoms of akathisia (awareness of restlessness and reported distress related to restlessness: range 0 to 3), and a global clinical rating of akathisia, ranging from 0 (absent) to 5 (severe). The global rating score, that is scored separately, is the most relevant measure of severity of akathisia. Higher scores denote worsening akathisia.
The SAS rates 10 items from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor and salivation. The SAS global score is the average score (total sum of items score divided by the number of items) and ranges between 0 and 4, where the higher score denotes more severe condition of extra pyramidal symptoms.
| Arm | Type | Description |
|---|---|---|
| Placebo First, Then Olanzapine | PLACEBO_COMPARATOR | Participants will receive 2 matching placebo capsules orally twice daily for 6 consecutive weeks, then 2 matching placebo capsules orally in the morning and olanzapine 10 milligram (mg) capsule along with matching placebo capsule orally in the evening for next 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 5 weeks. |
| JNJ-37822681 10 mg | EXPERIMENTAL | Participants will receive 1 matching placebo capsule along with JNJ-37822681 10 mg capsule orally twice a day for 12 consecutive weeks. |
| JNJ-37822681 20 mg | EXPERIMENTAL | Participants will receive 1 matching placebo capsule along with JNJ-37822681 20 mg capsule orally twice a day for 12 consecutive weeks. |
| JNJ-37822681 30 mg | EXPERIMENTAL | Participants will receive JNJ-37822681 30 mg (one 10 mg capsule along with JNJ-37822681 20 mg capsule) orally twice a day for 12 consecutive weeks. |
| Olanzapine | ACTIVE_COMPARATOR | Participants will receive 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with matching placebo capsule orally in the evening for 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 11 consecutive weeks. |
| JNJ-37822681 10 milligram | EXPERIMENTAL | JNJ-37822681 oral capsule will be administered at a starting dose of 10 milligram (mg) twice daily for the first 3 days and thereafter dose will be titrated from Day 3 to Day 10 up to 80 mg per day and will be continued at same dose up to Day 14. |
| JNJ-37822681 20 milligram and placebo | EXPERIMENTAL | JNJ-37822681 oral capsule will be administered at a starting dose of 20 mg once daily for the first 3 days and thereafter dose will be titrated from Day 3 to Day 10 up to 80 mg per day and will be continued at same dose up to Day 14. Matching Placebo will be administered orally in the evening for 14 days (12 hour post JNJ-37822681 administration). |
| Name | Type | Description |
|---|---|---|
| JNJ-37822681 | DRUG | Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks. |
| Olanzapine | DRUG | Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks. |
| Placebo | DRUG | Participants will receive matching placebo capsules orally for 12 weeks. |
Inclusion Criteria: * Participants must have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening * Participants must be experiencing an acute (a quick a...
JNJ-37822681 is an investigational small molecule being developed for the treatment of schizophrenia. It is a Phase 2 candidate studied in patients with this psychiatric condition. The drug is not approved and remains in clinical development.
JNJ-37822681 is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company has sponsored clinical trials evaluating the drug in participants with schizophrenia.
JNJ-37822681 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both involving patients with schizophrenia. The drug is investigational and has not been approved by regulatory authorities.
JNJ-37822681 has been studied in two completed Phase 2 trials. NCT00728195 evaluated three fixed doses in 498 participants with schizophrenia across multiple countries. NCT01812642 assessed safety and tolerability in 33 participants with stable schizophrenia.
No alternative names for JNJ-37822681 have been disclosed. The drug is identified solely by its compound number in clinical trial records and development documentation.