Flexible-dose, Long-term Safety Study of Lu AF35700 in Adult Patients With Schizophrenia
NCT ID: NCT02892422
Last Updated: 2020-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
528 participants
INTERVENTIONAL
2016-08-31
2019-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Flexible-dose of Lu AF35700
Lu AF35700
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)
Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
Interventions
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Lu AF35700
Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)
Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study
Eligibility Criteria
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Inclusion Criteria
* The patient has completed Study 16159A.
* The patient is able to read and understand the Informed Consent Form.
* The patient has signed the Informed Consent Form specific for Study 16159B.
* The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
For 16323A-patients
* The patient has completed the dosing period of Study 16323A.
* The patient is able to read and understand the Informed Consent Form.
* The patient has signed the Informed Consent Form specific Study 16159B.
* The patient has a confirmed diagnosis of schizophrenia according to DSM-5™.
* The patient can potentially benefit from 52-week treatment with Lu AF35700 according to the investigator's clinical judgement.
For Other Patients
* The patient has schizophrenia, diagnosed according to DSM-5™.
* The patient is a man or woman, aged ≥18 years.
* The patient has been prescribed oral antipsychotic treatment at the recommended dose range as stated in the summary of product characteristics or equivalent label for 6 weeks prior to the Screening Visit.
* The patient has a PANSS total score ≥60 and ≤90 at Screening and Baseline Visits.
* The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4.
* The patient is in need of a change in the current antipsychotic treatment and, according to the investigator's clinical judgement, the patient can potentially benefit from a switch to another treatment including, but not limited to, any of the following reasons:
* lack of adequate response to his or her current antipsychotic medication;
* poor tolerability to his or her current antipsychotic medication;
* unwillingness of the patient to adhere to his or her current antipsychotic medication.
Exclusion Criteria
* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16159A.
* The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the Columbia-Suicide Severity Rating Scale (C-SSRS), OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For 16323A-patients
* The patient has been diagnosed with a primary psychiatric disorder other than schizophrenia during Study 16323A.
* The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
For Other Patients
* The patient has any current psychiatric disorder (DSM-5™ criteria) other than schizophrenia established as the primary diagnosis.
* The patient is experiencing acute exacerbation of psychotic symptoms at the Screening Visit, between the Screening and Baseline Visits or at the Baseline Visit.
* The patient is treated with clozapine at the time of the Screening Visit.
* The patient has a substance use disorder (except nicotine) which according to the investigator's judgment may compromise the patient's ability to comply with the study procedures, or preclude the benefits of the study medication.
* The patient, in the opinion of the investigator, is at significant risk of suicide, or: Answers "Yes" to any question on the Suicidal Behaviour section of the C-SSRS, OR Answers "Yes" to questions 4 and 5 on the Suicidal Ideation section of the C-SSRS
18 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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US1018
Bellflower, California, United States
US1062
Costa Mesa, California, United States
US1463
Culver City, California, United States
US1399
Escondido, California, United States
US1104
Garden Grove, California, United States
US1114
National City, California, United States
US1459
Oceanside, California, United States
US1368
Orange, California, United States
US1391
San Bernardino, California, United States
US1392
Torrance, California, United States
US1318
Lauderhill, Florida, United States
US1130
Miami, Florida, United States
US1129
North Miami, Florida, United States
US1402
Oakland Park, Florida, United States
US1403
Atlanta, Georgia, United States
US1009
Atlanta, Georgia, United States
US1046
Chicago, Illinois, United States
US1423
Hoffman Estates, Illinois, United States
US1398
Shreveport, Louisiana, United States
US1404
Shreveport, Louisiana, United States
US1086
Flowood, Mississippi, United States
US1444
Las Vegas, Nevada, United States
US1426
Berlin, New Jersey, United States
US1244
Fresh Meadows, New York, United States
US1394
New York, New York, United States
US1416
New York, New York, United States
US1171
Rochester, New York, United States
US1190
Staten Island, New York, United States
US1390
Charlotte, North Carolina, United States
US1124
Norristown, Pennsylvania, United States
US1451
Austin, Texas, United States
US1065
Dallas, Texas, United States
BG1030
Burgas, , Bulgaria
BG1028
Kazanlak, , Bulgaria
BG1003
Lovech, , Bulgaria
BG1008
Plovdiv, , Bulgaria
BG1024
Sofia, , Bulgaria
BG1026
Sofia, , Bulgaria
BG1034
Varna, , Bulgaria
BG1029
Veliko Tarnovo, , Bulgaria
BG1027
Vratsa, , Bulgaria
CA1029
Penticton, , Canada
CZ1023
Brno, , Czechia
CZ1032
Brno, , Czechia
CZ1013
Lnáře, , Czechia
CZ1038
Prague, , Czechia
EE1007
Tallinn, , Estonia
MX1024
Durango, , Mexico
MX1011
Guadalajara, , Mexico
MX1021
Guadalajara, , Mexico
MX1022
Guadalajara, , Mexico
MX1020
Mexico City, , Mexico
MX1005
Monterrey, , Mexico
MX1007
Monterrey, , Mexico
MX1015
Monterrey, , Mexico
PL1043
Bialystok, , Poland
PL1060
Lodz, , Poland
PL1058
Pruszcz Gdański, , Poland
PL1059
Torun, , Poland
PL1051
Wroclaw, , Poland
RO1024
Bucharest, , Romania
RU1009
Arkhangelsk, , Russia
RU1021
Gatchina, , Russia
RU1006
Moscow, , Russia
RU1051
Moscow, , Russia
RU1055
Moscow, , Russia
RU1053
Roshchino, , 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
RU1056
Saint Petersburg, , Russia
RU1050
Yaroslavl, , Russia
RS1008
Belgrade, , Serbia
RS1010
Belgrade, , Serbia
RS1012
Belgrade, , Serbia
RS1001
Kovin, , Serbia
RS1011
Kragujevac, , Serbia
RS1016
Kragujevac, , Serbia
RS1017
Kragujevac, , Serbia
RS1009
Novi Kneževac, , Serbia
SK1014
Bratislava, , Slovakia
SK1024
Bratislava, , Slovakia
SK1026
Zlaté Moravce, , Slovakia
ES1047
Barcelona, , Spain
ES1008
Málaga, , Spain
ES1048
Oviedo, , Spain
UA1017
Kharkiv, , Ukraine
UA1035
Kharkiv, , Ukraine
UA1029
Kherson, , Ukraine
UA1027
Kiev, , Ukraine
UA1028
Kiev, , Ukraine
UA1030
Kiev, , Ukraine
UA1031
Kiev, , Ukraine
UA1033
Lviv, , Ukraine
UA1019
Odesa, , Ukraine
UA1020
Odesa, , Ukraine
UA1032
Oleksandrivka, , Ukraine
UA1001
Poltava, , Ukraine
UA1036
Vinnitsa, , Ukraine
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003284-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16159B
Identifier Type: -
Identifier Source: org_study_id