search
Back to results

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (DayBreak)

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Risperidone
Olanzapine
Lu AF35700
Lu AF35700
Sponsored by
H. Lundbeck A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
  • The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
  • Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
  • The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
  • The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
  • The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

Exclusion Criteria:

  • The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
  • The patient is experiencing an acute exacerbation of his/her psychotic symptoms
  • The patient has not responded to treatment with clozapine

Other protocol defined inclusion and exclusion criteria may apply

Sites / Locations

  • US1018
  • US1041
  • US1062
  • US1463
  • US1104
  • US1118
  • US1114
  • US1452
  • US1459
  • US1399
  • US1368
  • US1391
  • US1464
  • US1384
  • US1392
  • US1396
  • US1395
  • US1253
  • US1130
  • US1318
  • US1129
  • US1402
  • US1229
  • US1453
  • US1403
  • US1009
  • US1442
  • US1046
  • US1423
  • US1398
  • US1404
  • US1086
  • US1444
  • US1426
  • US1454
  • US1405
  • US1244
  • US1394
  • US1416
  • US1171
  • US1190
  • US1390
  • US1401
  • US1441
  • US1124
  • US1319
  • US1451
  • US1065
  • US1443
  • BG1030
  • BG1028
  • BG1003
  • BG1032
  • BG1008
  • BG1024
  • BG1026
  • BG1022
  • BG1033
  • BG1034
  • BG1029
  • BG1027
  • CA1017
  • CA1034
  • CA1003
  • CA1033
  • CA1029
  • CA1039
  • CZ1023
  • CZ1032
  • CZ1037
  • CZ1013
  • CZ1038
  • EE1016
  • EE1007
  • EE1017
  • FI1032
  • FI1030
  • FI1027
  • MX1024
  • MX1011
  • MX1021
  • MX1022
  • MX1020
  • MX1005
  • MX1007
  • MX1015
  • MX1016
  • MX1018
  • PL1025
  • PL1043
  • PL1026
  • PL1060
  • PL1027
  • PL1058
  • PL1061
  • PL1059
  • PL1051
  • RO1024
  • RO1022
  • RO1025
  • RO1004
  • RU1021
  • RU1009
  • RU1006
  • RU1051
  • RU1055
  • RU1023
  • RU1028
  • RU1030
  • RU1031
  • RU1052
  • RU1053
  • RU1056
  • RU1049
  • RU1050
  • RS1008
  • RS1010
  • RS1012
  • RS1011
  • RS1016
  • RS1017
  • RS1003
  • RS1009
  • SK1014
  • SK1024
  • SK1015
  • SK1025
  • SK1026
  • ES1047
  • ES1012
  • ES1008
  • ES1048
  • ES1049
  • UA1019
  • UA1017
  • UA1022
  • UA1031
  • UA1035
  • UA1028
  • UA1029
  • UA1027
  • UA1030
  • UA1033
  • UA1020
  • UA1032
  • UA1001
  • UA1036

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Prospective Confirmation (PC) Period

Double-blind Treatment (DBT) Period, Lu AF35700 10 mg

DBT Period, Lu AF35700 20 mg

DBT Period, Continued treatment from PC Period

Arm Description

Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 11, 2016
Last Updated
October 30, 2019
Sponsor
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT02717195
Brief Title
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Acronym
DayBreak
Official Title
Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 30, 2018 (Actual)
Study Completion Date
October 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1098 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prospective Confirmation (PC) Period
Arm Type
Experimental
Arm Description
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Arm Title
Double-blind Treatment (DBT) Period, Lu AF35700 10 mg
Arm Type
Experimental
Arm Description
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
Arm Title
DBT Period, Lu AF35700 20 mg
Arm Type
Experimental
Arm Description
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
Arm Title
DBT Period, Continued treatment from PC Period
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Description
4-6 mg/day, encapsulated tablets, orally
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Intervention Description
15-20 mg/day, encapsulated tablets, orally
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Description
10 mg/day, encapsulated tablets, orally
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Description
20 mg/day, encapsulated tablets, orally
Primary Outcome Measure Information:
Title
Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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.
Time Frame
From Randomization to Week 10
Secondary Outcome Measure Information:
Title
Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score
Description
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.
Time Frame
From Randomization to Week 10
Title
Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score
Description
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.
Time Frame
From Randomization to Week 10
Title
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
Description
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.
Time Frame
From Randomization to Week 10
Title
Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
Description
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.
Time Frame
From Randomization to Week 10
Title
Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization
Description
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.
Time Frame
From Randomization to Week 10
Title
Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
Description
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.
Time Frame
From Randomization to Week 10
Title
Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization
Description
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.
Time Frame
From Randomization to Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist. Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s) The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A) The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A Exclusion Criteria: The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI) The patient is experiencing an acute exacerbation of his/her psychotic symptoms The patient has not responded to treatment with clozapine Other protocol defined inclusion and exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
US1018
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
US1041
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
US1062
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
US1463
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Facility Name
US1104
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
US1118
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
US1114
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
US1452
City
Oceanside
State/Province
California
ZIP/Postal Code
92056-4509
Country
United States
Facility Name
US1459
City
Oceanside
State/Province
California
ZIP/Postal Code
92056-4515
Country
United States
Facility Name
US1399
City
Orange
State/Province
California
ZIP/Postal Code
91945
Country
United States
Facility Name
US1368
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
US1391
City
San Bernardino
State/Province
California
ZIP/Postal Code
92408-3332
Country
United States
Facility Name
US1464
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705-3610
Country
United States
Facility Name
US1384
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403-1747
Country
United States
Facility Name
US1392
City
Torrance
State/Province
California
ZIP/Postal Code
90502-4432
Country
United States
Facility Name
US1396
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
US1395
City
Bradenton
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
US1253
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
US1130
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
US1318
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
US1129
City
North Miami
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
US1402
City
Oakland Park
State/Province
Florida
ZIP/Postal Code
33334-4400
Country
United States
Facility Name
US1229
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
US1453
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609-2231
Country
United States
Facility Name
US1403
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
US1009
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
US1442
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
US1046
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
US1423
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169-1067
Country
United States
Facility Name
US1398
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4603
Country
United States
Facility Name
US1404
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104-2136
Country
United States
Facility Name
US1086
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
US1444
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102-1943
Country
United States
Facility Name
US1426
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
US1454
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
US1405
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
US1244
City
Jamaica
State/Province
New York
ZIP/Postal Code
11432
Country
United States
Facility Name
US1394
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
US1416
City
New York
State/Province
New York
ZIP/Postal Code
10035-6000
Country
United States
Facility Name
US1171
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
US1190
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
US1390
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204-3110
Country
United States
Facility Name
US1401
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211-1064
Country
United States
Facility Name
US1441
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601-5045
Country
United States
Facility Name
US1124
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
US1319
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
US1451
City
Austin
State/Province
Texas
ZIP/Postal Code
78754-5122
Country
United States
Facility Name
US1065
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
US1443
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
BG1030
City
Burgas
Country
Bulgaria
Facility Name
BG1028
City
Kazanlak
Country
Bulgaria
Facility Name
BG1003
City
Lovech
Country
Bulgaria
Facility Name
BG1032
City
Pazardzhik
Country
Bulgaria
Facility Name
BG1008
City
Plovdiv
Country
Bulgaria
Facility Name
BG1024
City
Sofia
Country
Bulgaria
Facility Name
BG1026
City
Sofia
Country
Bulgaria
Facility Name
BG1022
City
Tserova Koria
Country
Bulgaria
Facility Name
BG1033
City
Varna
Country
Bulgaria
Facility Name
BG1034
City
Varna
Country
Bulgaria
Facility Name
BG1029
City
Veliko Tŭrnovo
Country
Bulgaria
Facility Name
BG1027
City
Vratsa
Country
Bulgaria
Facility Name
CA1017
City
Chatham
Country
Canada
Facility Name
CA1034
City
Kingston
Country
Canada
Facility Name
CA1003
City
Montréal
Country
Canada
Facility Name
CA1033
City
Montréal
Country
Canada
Facility Name
CA1029
City
Penticton
Country
Canada
Facility Name
CA1039
City
Québec
Country
Canada
Facility Name
CZ1023
City
Brno
Country
Czechia
Facility Name
CZ1032
City
Brno
Country
Czechia
Facility Name
CZ1037
City
Hostivice
Country
Czechia
Facility Name
CZ1013
City
Lnare
Country
Czechia
Facility Name
CZ1038
City
Praha
Country
Czechia
Facility Name
EE1016
City
Pärnu
Country
Estonia
Facility Name
EE1007
City
Tallinn
Country
Estonia
Facility Name
EE1017
City
Viljandi
Country
Estonia
Facility Name
FI1032
City
Espoo
Country
Finland
Facility Name
FI1030
City
Kuopio
Country
Finland
Facility Name
FI1027
City
Turku
Country
Finland
Facility Name
MX1024
City
Durango
Country
Mexico
Facility Name
MX1011
City
Guadalajara
Country
Mexico
Facility Name
MX1021
City
Guadalajara
Country
Mexico
Facility Name
MX1022
City
Guadalajara
Country
Mexico
Facility Name
MX1020
City
Mexico
Country
Mexico
Facility Name
MX1005
City
Monterrey
Country
Mexico
Facility Name
MX1007
City
Monterrey
Country
Mexico
Facility Name
MX1015
City
Monterrey
Country
Mexico
Facility Name
MX1016
City
Monterrey
Country
Mexico
Facility Name
MX1018
City
San Luis Potosi
Country
Mexico
Facility Name
PL1025
City
Bełchatów
Country
Poland
Facility Name
PL1043
City
Bialystok
Country
Poland
Facility Name
PL1026
City
Gorlice
Country
Poland
Facility Name
PL1060
City
Lodz
Country
Poland
Facility Name
PL1027
City
Lublin
Country
Poland
Facility Name
PL1058
City
Pruszcz Gdanski
Country
Poland
Facility Name
PL1061
City
Pruszkow
Country
Poland
Facility Name
PL1059
City
Torun
Country
Poland
Facility Name
PL1051
City
Wroclaw
Country
Poland
Facility Name
RO1024
City
Bucuresti
Country
Romania
Facility Name
RO1022
City
Câmpulung
Country
Romania
Facility Name
RO1025
City
Sibiu
Country
Romania
Facility Name
RO1004
City
Târgu-Mureş
Country
Romania
Facility Name
RU1021
City
Nikol'skoye
State/Province
Gatchinckiy District
Country
Russian Federation
Facility Name
RU1009
City
Arkhangelsk
Country
Russian Federation
Facility Name
RU1006
City
Moscow
Country
Russian Federation
Facility Name
RU1051
City
Moscow
Country
Russian Federation
Facility Name
RU1055
City
Moscow
Country
Russian Federation
Facility Name
RU1023
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1028
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1030
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1031
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1052
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1053
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1056
City
Saint Petersburg
Country
Russian Federation
Facility Name
RU1049
City
St. Petersburg
Country
Russian Federation
Facility Name
RU1050
City
Yaroslavl
Country
Russian Federation
Facility Name
RS1008
City
Belgrade
Country
Serbia
Facility Name
RS1010
City
Belgrade
Country
Serbia
Facility Name
RS1012
City
Belgrade
Country
Serbia
Facility Name
RS1011
City
Kragujevac
Country
Serbia
Facility Name
RS1016
City
Kragujevac
Country
Serbia
Facility Name
RS1017
City
Kragujevac
Country
Serbia
Facility Name
RS1003
City
Nis
Country
Serbia
Facility Name
RS1009
City
Novi Knezevac
Country
Serbia
Facility Name
SK1014
City
Bratislava
Country
Slovakia
Facility Name
SK1024
City
Bratislava
Country
Slovakia
Facility Name
SK1015
City
Roznava
Country
Slovakia
Facility Name
SK1025
City
Svidnik
Country
Slovakia
Facility Name
SK1026
City
Zlate Moravce
Country
Slovakia
Facility Name
ES1047
City
Barcelona
Country
Spain
Facility Name
ES1012
City
Madrid
Country
Spain
Facility Name
ES1008
City
Malaga
Country
Spain
Facility Name
ES1048
City
Oviedo
Country
Spain
Facility Name
ES1049
City
Zamora
Country
Spain
Facility Name
UA1019
City
Dnipropetrovsk
Country
Ukraine
Facility Name
UA1017
City
Kharkiv
Country
Ukraine
Facility Name
UA1022
City
Kharkiv
Country
Ukraine
Facility Name
UA1031
City
Kharkiv
Country
Ukraine
Facility Name
UA1035
City
Kharkiv
Country
Ukraine
Facility Name
UA1028
City
Kherson
Country
Ukraine
Facility Name
UA1029
City
Kherson
Country
Ukraine
Facility Name
UA1027
City
Kiev
Country
Ukraine
Facility Name
UA1030
City
Kiev
Country
Ukraine
Facility Name
UA1033
City
Lviv
Country
Ukraine
Facility Name
UA1020
City
Odessa
Country
Ukraine
Facility Name
UA1032
City
Odessa
Country
Ukraine
Facility Name
UA1001
City
Poltava
Country
Ukraine
Facility Name
UA1036
City
Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
36115192
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

We'll reach out to this number within 24 hrs