| Primary | Change From Baseline to Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score | The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS total score can range from a minimum of 30 to a maximum of 210, where a higher score signifies greater severity of schizophrenia symptoms. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
| | | Title | Denominators | Categories |
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| Baseline | - ParticipantsOG000193
- ParticipantsOG001196
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | mixed-effects model for repeated measure | | 0.0940 | | Difference in MMRM LSMs | -2.1 | Standard Error of the Mean | 1.24 | 2-Sided | 95 | -4.5 | 0.4 | | | | | Superiority | | |
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| Secondary | Change From Baseline to Week 6 in the Clinical Global Impression-Severity (CGI-S) Score | The CGI-S is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-S score denotes greater severity of the disorder. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Change From Baseline (CFBL) to Week 6 in PANSS Subscale Scores, i.e. PANSS Positive Subscale Score, PANSS Negative Subscale Score and PANSS General Psychopathological Scale Score | The PANSS is a 30-item scale used to evaluate the presence, absence, and severity of schizophrenia symptoms. The 30 items are arranged as 7 positive symptom items (P1 to P7), 7 negative symptom items (N1 to N7), and 16 general psychopathology symptom items (G1 to G16). Items are scored over the past week (7 days) on a 7-point scale ranging from 1 (absent) to 7 (extreme). The PANSS positive subscale score can range from 7 to 49; the PANSS negative subscale score can range from 7 to 49; the PANSS general psychopathology scale score can range from 16 to 112. For each of the subscale scores, a higher score signifies greater severity of schizophrenia symptoms. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo |
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| Secondary | PANSS Responders | Porportion of patients showing a PANSS response of >=20% or >=30% reduction in PANSS total score PANSS total score reduction signifies improvement. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Count of Participants | | Participants | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Response | The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement. A CGI-I score of 1 or 2 was counted as response. The Analysis was performed twice; once including missing values as non-responders (MN) and once including only observed cases (OC). | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Count of Participants | | Participants | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Score at Week 6 | The CGI-I is a 1-item scale, used to rate the improvement from 1 (very much improved) to 7 (very much worse). Higher scores denote less improvement. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Change From Baseline to Week 6 in Personal and Social Performance (PSP) Scale Score | The PSP is a validated 100-point (1 to100) single-item rating scale to assess the psychosocial functioning of patients with schizophrenia. The maximum score is 100. Higher scores denote better psychosocial functioning. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Drug Attitude Inventory (DAI-10) | The DAI-10 contains 6 items (1, 3, 4, 7, 9, and 10) that a patient who is fully adherent to study medication would answer as "True" and 4 items (2, 5, 6, and 8) that a patient who is fully adherent to study medication would answer as "False." A correct answer is scored +1 and an incorrect answer is scored -1; the total score is derived as overall sum. The score can range from -10 to 10. Positive total scores indicate adherence and negative total scores indicate non-adherence. Higher scores denote better adherence. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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| Secondary | Change From Baseline to Week 6 in Karolinska Sleepiness Scale (KSS) Score | The KSS is a self-reported measure of a patient's level of drowsiness. In this study, drowsiness was to be rated during the last week (7 days). Scoring is based on a 9-point verbally anchored scale ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep). The maximum score is 9. Higher scores denote more drowsiness. | Patients randomised and treated (at least 1 dose of study medication) who had both a baseline value and at least 1 post-baseline value for the PANSS total score. | Posted | | Mean | Standard Error | score on a scale | | From baseline to Week 6 | | | | ID | Title | Description |
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| OG000 | Pimavanserin | Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study. Patients were to continue their background antipsychotic treatment. | | OG001 | Placebo | Pimavanserin-matching Placebo. Patients were to continue their background antipsychotic treatment. |
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