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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003569-12 | EudraCT Number |
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To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
The study consists of a Screening Period (3 weeks), a single-blind Prospective Confirmation (PC) Period (6 weeks), a Double-blind Treatment (DBT) Period (10 weeks), and a Safety Follow-up Period (6 weeks).
Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.
Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period and were randomized into one of 3 treatment arms (1:1:1) with either Lu AF35700 10 mg/day, Lu AF35700 20 mg/day or to continue the treatment allocated in PC Period (olanzapine or risperidone) at the dose set at last visit of PC Period. This mean that approximately one third of the confirmed treatment-resistant patients were randomised back to the failed treatment used in the PC Period.
Data was not collected separately for the DBT Olanzapine and DBT Risperidone participants, and there was no intent to compare Lu AF35700 to each drug separately.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Confirmation (PC) Period | Experimental | Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks |
|
| Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Experimental | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks |
|
| DBT Period, Lu AF35700 20 mg | Experimental | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks |
|
| DBT Period, Continued treatment from PC Period | Experimental | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | 4-6 mg/day, encapsulated tablets, orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. | From Randomization to Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | LundbeckClinicalTrials@Lundbeck.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US1018 | Bellflower | California | 90706 | United States | ||
| US1041 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36115192 | Derived | Kane JM, Kinon BJ, Forray C, Such P, Mittoux A, Lemming OM, Hertel P, Howes OD; DayBreak and Debut study investigators. Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension. Schizophr Res. 2022 Oct;248:271-278. doi: 10.1016/j.schres.2022.09.012. Epub 2022 Sep 14. |
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Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period. Patients who fulfilled the randomization criteria for the DBT Period, continued into the DBT Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Confirmation (PC) Period, Risperidone | Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks Risperidone: 4-6 mg/day, encapsulated tablets, orally |
| FG001 | PC Period, Olanzapine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Prospective Confirmation (PC) Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2017 | Aug 29, 2019 |
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| Olanzapine | Drug | 15-20 mg/day, encapsulated tablets, orally |
|
| Lu AF35700 | Drug | 10 mg/day, encapsulated tablets, orally |
|
| Lu AF35700 | Drug | 20 mg/day, encapsulated tablets, orally |
|
| From Randomization to Week 10 |
| Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening. | From Randomization to Week 10 |
| Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement. | From Randomization to Week 10 |
| Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | From Randomization to Week 10 |
| Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | From Randomization to Week 10 |
| Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | From Randomization to Week 10 |
| Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | From Randomization to Week 10 |
| Cerritos |
| California |
| 90703 |
| United States |
| US1062 | Costa Mesa | California | 92626 | United States |
| US1463 | Culver City | California | 90230 | United States |
| US1104 | Garden Grove | California | 92845 | United States |
| US1118 | Glendale | California | 91206 | United States |
| US1114 | National City | California | 91950 | United States |
| US1452 | Oceanside | California | 92056-4509 | United States |
| US1459 | Oceanside | California | 92056-4515 | United States |
| US1399 | Orange | California | 91945 | United States |
| US1368 | Orange | California | 92868 | United States |
| US1391 | San Bernardino | California | 92408-3332 | United States |
| US1464 | Santa Ana | California | 92705-3610 | United States |
| US1384 | Sherman Oaks | California | 91403-1747 | United States |
| US1392 | Torrance | California | 90502-4432 | United States |
| US1396 | Washington D.C. | District of Columbia | 20016 | United States |
| US1395 | Bradenton | Florida | 32751 | United States |
| US1253 | Jacksonville | Florida | 32256 | United States |
| US1130 | Miami | Florida | 33122 | United States |
| US1318 | North Miami | Florida | 33161 | United States |
| US1129 | North Miami | Florida | 33162 | United States |
| US1402 | Oakland Park | Florida | 33334-4400 | United States |
| US1229 | Orange City | Florida | 32763 | United States |
| US1453 | Tampa | Florida | 33609-2231 | United States |
| US1403 | Atlanta | Georgia | 30328 | United States |
| US1009 | Atlanta | Georgia | 30331 | United States |
| US1442 | Decatur | Georgia | 30030 | United States |
| US1046 | Chicago | Illinois | 60640 | United States |
| US1423 | Hoffman Estates | Illinois | 60169-1067 | United States |
| US1398 | Shreveport | Louisiana | 71101-4603 | United States |
| US1404 | Shreveport | Louisiana | 71104-2136 | United States |
| US1086 | Flowood | Mississippi | 39232 | United States |
| US1444 | Las Vegas | Nevada | 89102-1943 | United States |
| US1426 | Berlin | New Jersey | 08009 | United States |
| US1454 | Marlton | New Jersey | 08053 | United States |
| US1405 | Glen Oaks | New York | 11004 | United States |
| US1244 | Jamaica | New York | 11432 | United States |
| US1394 | New York | New York | 10032 | United States |
| US1416 | New York | New York | 10035-6000 | United States |
| US1171 | Rochester | New York | 14618 | United States |
| US1190 | Staten Island | New York | 10312 | United States |
| US1390 | Charlotte | North Carolina | 28204-3110 | United States |
| US1401 | Charlotte | North Carolina | 28211-1064 | United States |
| US1441 | Hickory | North Carolina | 28601-5045 | United States |
| US1124 | Norristown | Pennsylvania | 19403 | United States |
| US1319 | Charleston | South Carolina | 29407 | United States |
| US1451 | Austin | Texas | 78754-5122 | United States |
| US1065 | Dallas | Texas | 75243 | United States |
| US1443 | Fort Worth | Texas | 76104 | United States |
| BG1030 | Burgas | Bulgaria |
| BG1028 | Kazanlak | Bulgaria |
| BG1003 | Lovech | Bulgaria |
| BG1032 | Pazardzhik | Bulgaria |
| BG1008 | Plovdiv | Bulgaria |
| BG1024 | Sofia | Bulgaria |
| BG1026 | Sofia | Bulgaria |
| BG1022 | Tserova Koria | Bulgaria |
| BG1033 | Varna | Bulgaria |
| BG1034 | Varna | Bulgaria |
| BG1029 | Veliko Tarnovo | Bulgaria |
| BG1027 | Vratsa | Bulgaria |
| CA1017 | Chatham | Canada |
| CA1034 | Kingston | Canada |
| CA1003 | Montreal | Canada |
| CA1033 | Montreal | Canada |
| CA1029 | Penticton | Canada |
| CA1039 | Québec | Canada |
| CZ1023 | Brno | Czechia |
| CZ1032 | Brno | Czechia |
| CZ1037 | Hostivice | Czechia |
| CZ1013 | Lnáře | Czechia |
| CZ1038 | Prague | Czechia |
| EE1016 | Pärnu | Estonia |
| EE1007 | Tallinn | Estonia |
| EE1017 | Viljandi | Estonia |
| FI1032 | Espoo | Finland |
| FI1030 | Kuopio | Finland |
| FI1027 | Turku | Finland |
| MX1024 | Durango | Mexico |
| MX1011 | Guadalajara | Mexico |
| MX1021 | Guadalajara | Mexico |
| MX1022 | Guadalajara | Mexico |
| MX1020 | México | Mexico |
| MX1005 | Monterrey | Mexico |
| MX1007 | Monterrey | Mexico |
| MX1015 | Monterrey | Mexico |
| MX1016 | Monterrey | Mexico |
| MX1018 | San Luis Potosà City | Mexico |
| PL1025 | Bełchatów | Poland |
| PL1043 | Bialystok | Poland |
| PL1026 | Gorlice | Poland |
| PL1060 | Lodz | Poland |
| PL1027 | Lublin | Poland |
| PL1058 | Pruszcz Gdański | Poland |
| PL1061 | Pruszków | Poland |
| PL1059 | Torun | Poland |
| PL1051 | Wroclaw | Poland |
| RO1024 | Bucharest | Romania |
| RO1022 | Campulung Muscel | Romania |
| RO1025 | Sibiu | Romania |
| RO1004 | Târgu Mureş | Romania |
| RU1021 | Nikol’skoye | Gatchinckiy District | Russia |
| RU1009 | Arkhangelsk | Russia |
| RU1006 | Moscow | Russia |
| RU1051 | Moscow | Russia |
| RU1055 | Moscow | Russia |
| RU1023 | Saint Petersburg | Russia |
| RU1028 | Saint Petersburg | Russia |
| RU1030 | Saint Petersburg | Russia |
| RU1031 | Saint Petersburg | Russia |
| RU1049 | Saint Petersburg | Russia |
| RU1052 | Saint Petersburg | Russia |
| RU1053 | Saint Petersburg | Russia |
| RU1056 | Saint Petersburg | Russia |
| RU1050 | Yaroslavl | Russia |
| RS1008 | Belgrade | Serbia |
| RS1010 | Belgrade | Serbia |
| RS1012 | Belgrade | Serbia |
| RS1011 | Kragujevac | Serbia |
| RS1016 | Kragujevac | Serbia |
| RS1017 | Kragujevac | Serbia |
| RS1003 | Niš | Serbia |
| RS1009 | Novi Kneževac | Serbia |
| SK1014 | Bratislava | Slovakia |
| SK1024 | Bratislava | Slovakia |
| SK1015 | Rožňava | Slovakia |
| SK1025 | SvidnÃk | Slovakia |
| SK1026 | Zlaté Moravce | Slovakia |
| ES1047 | Barcelona | Spain |
| ES1012 | Madrid | Spain |
| ES1008 | Málaga | Spain |
| ES1048 | Oviedo | Spain |
| ES1049 | Zamora | Spain |
| UA1019 | Dnipropetrovsk | Ukraine |
| UA1017 | Kharkiv | Ukraine |
| UA1022 | Kharkiv | Ukraine |
| UA1031 | Kharkiv | Ukraine |
| UA1035 | Kharkiv | Ukraine |
| UA1028 | Kherson | Ukraine |
| UA1029 | Kherson | Ukraine |
| UA1027 | Kiev | Ukraine |
| UA1030 | Kiev | Ukraine |
| UA1033 | Lviv | Ukraine |
| UA1020 | Odesa | Ukraine |
| UA1032 | Odesa | Ukraine |
| UA1001 | Poltava | Ukraine |
| UA1036 | Vinnitsa | Ukraine |
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Olanzapine: 15-20 mg/day, encapsulated tablets, orally
| FG002 | Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks |
| FG003 | DBT Period, Lu AF35700 20 mg | Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks |
| FG004 | DBT Period, Continued Treatment From PC Period | Patients in this arm will continue the treatment allocated in the PC Period at the dose set at last visit of the PC Period. The analysis is made independent on which treatment the patient was on (risperidone or olanzapine) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-blind Treatment (DBT) Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Non-randomized Patients | Patients not randomized into the double-blind treatment period, i.e. withdrawn from the study during or after the PC period, were analyzed as one arm independent of treatment. |
| BG001 | Double-blind Treatment (DBT) Period, Lu AF35700 10 mg | Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks |
| BG002 | DBT Period, Lu AF35700 20 mg | Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks |
| BG003 | DBT Period, Continued Treatment From PC Period | Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| PANSS total score | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| CGI-S score | CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Mean | Standard Error | units on a scale | From Randomization to Week 10 |
|
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| Secondary | Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score | PSP is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. It consists of 4 items: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviours. Each items were assessed on a 6-point scale, from 1 (absent) to 6 (very severe). PSP score was calculated as sum of all the items on the scale and ranged from 4 to 100. A higher score represents more severe functional impairment. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Mean | Standard Error | units on a scale | From Randomization to Week 10 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score | CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate worsening. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Mean | Standard Error | units on a scale | From Randomization to Week 10 |
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| Secondary | Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. The Clinical Global Impression scale - severity of illness (CGI-S) is administered by the investigator. The patient is rated on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). A reduction in scale indicates improvement. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Count of Participants | Participants | From Randomization to Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Count of Participants | Participants | From Randomization to Week 10 |
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| Secondary | Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization | Positive and Negative Syndrome Scale (PANSS) total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Count of Participants | Participants | From Randomization to Week 10 |
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| Secondary | Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Count of Participants | Participants | From Randomization to Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization | PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia. A reduction in score indicates improvement. | Only patients randomized to receive double-blind treatment in the DBT Period are analysed. Patients randomized into the DBT period with risperidone or olanzapine were analyzed as one arm independent of treatment. Overall Number of Participants Analysed is number of patients in the FAS with a week 10 observation. | Posted | Count of Participants | Participants | From Randomization to Week 10 |
|
22 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Confirmation (PC) Period, Risperidone | Patients not randomized to double-blind treatment | 0 | 708 | 14 | 708 | 60 | 708 |
| EG001 | PC Period, Olanzapine | Patients not randomized to double-blind treatment | 0 | 384 | 7 | 384 | 45 | 384 |
| EG002 | Double Blind Treatment (DBT) Period, Lu AF35700 10 mg | Lu AF35700: 10 mg/day, encapsulated tablets, orally for 10 weeks | 0 | 234 | 6 | 234 | 20 | 235 |
| EG003 | DBT Period, Lu AF35700 20 mg | Lu AF35700: 20 mg/day, encapsulated tablets, orally for 10 weeks | 0 | 232 | 5 | 232 | 40 | 232 |
| EG004 | DBT Period, Continued Treatment From PC Period | Patients in this arm continued with the same treatment and dose as at the last visit of the PC Period. This arm is analyzed as one single treatment arm independent on which treatment was administered (olanzapine or risperidone). | 1 | 230 | 5 | 230 | 25 | 230 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Paranoia | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Social stay hospitalisation | Social circumstances | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Psychosocial support | Surgical and medical procedures | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA - 21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA - 21.0 | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@lundbeck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2018 | Aug 29, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| C000726227 | Lu AF35700 |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Lack of Efficacy |
|
| Non-compliance with IMP |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Enrolled but not treated |
|
| Patient decision |
|
| Investigator decision |
|
| Family circumstances |
|
| Change of residence |
|
| Needed antidepressant medication |
|
| Psychosocial issues |
|
| Patient missed required visits |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Superiority |
| The mean changes from Randomization in PANSS total score was analysed using a MMRM approach. The model included the fixed, categorical effects of treatment, country, week, treatment-by-week interaction, PC Period treatment, PC Period treatment-by-week interaction, and the continuous covariates of Randomization score and Randomization score-by-week interaction with an unstructured covariance structure to model the within-patient errors. | Mixed model repeated measures | 0.1474 | Multiplicity adjustment was planned for the testing of the primary endpoint, but was not applied since all p-values>0.05. | Mean Difference (Final Values) | 1.67 | 2-Sided | 95 | -0.59 | 3.94 | Superiority |
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
|
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
| OG001 | DBT Period, Lu AF35700 20 mg | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period, 10 weeks Lu AF35700: 20 mg/day, encapsulated tablets, orally |
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|
| OG002 | DBT Period, Continued Treatment From PC Period | Eligible patients from PC Period (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) double-blind treatment in DBT Period,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of PC Period Risperidone: 4-6 mg/day, encapsulated tablets, orally Olanzapine: 15-20 mg/day, encapsulated tablets, orally |
|
|