Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Schizophrenia Clinical Trial

— DayBreak  

Official title:

Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717195
• Other study ID #: 16159A
• Secondary ID: 2014-003569-12
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: October 8, 2018

Study information

• Verified date: October 2019
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1098
• Est. completion date: October 8, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone
4-6 mg/day, encapsulated tablets, orally
• Olanzapine
15-20 mg/day, encapsulated tablets, orally
• Lu AF35700
10 mg/day, encapsulated tablets, orally
• Lu AF35700
20 mg/day, encapsulated tablets, orally

Locations

Country	Name	City	State
Bulgaria	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 Turnovo
Bulgaria	BG1027	Vratsa
Canada	CA1017	Chatham
Canada	CA1034	Kingston
Canada	CA1003	Montréal
Canada	CA1033	Montréal
Canada	CA1029	Penticton
Canada	CA1039	Québec
Czechia	CZ1023	Brno
Czechia	CZ1032	Brno
Czechia	CZ1037	Hostivice
Czechia	CZ1013	Lnare
Czechia	CZ1038	Praha
Estonia	EE1016	Pärnu
Estonia	EE1007	Tallinn
Estonia	EE1017	Viljandi
Finland	FI1032	Espoo
Finland	FI1030	Kuopio
Finland	FI1027	Turku
Mexico	MX1024	Durango
Mexico	MX1011	Guadalajara
Mexico	MX1021	Guadalajara
Mexico	MX1022	Guadalajara
Mexico	MX1020	Mexico
Mexico	MX1005	Monterrey
Mexico	MX1007	Monterrey
Mexico	MX1015	Monterrey
Mexico	MX1016	Monterrey
Mexico	MX1018	San Luis Potosi
Poland	PL1025	Belchatów
Poland	PL1043	Bialystok
Poland	PL1026	Gorlice
Poland	PL1060	Lodz
Poland	PL1027	Lublin
Poland	PL1058	Pruszcz Gdanski
Poland	PL1061	Pruszkow
Poland	PL1059	Torun
Poland	PL1051	Wroclaw
Romania	RO1024	Bucuresti
Romania	RO1022	Câmpulung
Romania	RO1025	Sibiu
Romania	RO1004	Târgu-Mures
Russian Federation	RU1009	Arkhangelsk
Russian Federation	RU1006	Moscow
Russian Federation	RU1051	Moscow
Russian Federation	RU1055	Moscow
Russian Federation	RU1021	Nikol'skoye	Gatchinckiy District
Russian Federation	RU1023	Saint Petersburg
Russian Federation	RU1028	Saint Petersburg
Russian Federation	RU1030	Saint Petersburg
Russian Federation	RU1031	Saint Petersburg
Russian Federation	RU1052	Saint Petersburg
Russian Federation	RU1053	Saint Petersburg
Russian Federation	RU1056	Saint Petersburg
Russian Federation	RU1049	St. Petersburg
Russian Federation	RU1050	Yaroslavl
Serbia	RS1008	Belgrade
Serbia	RS1010	Belgrade
Serbia	RS1012	Belgrade
Serbia	RS1011	Kragujevac
Serbia	RS1016	Kragujevac
Serbia	RS1017	Kragujevac
Serbia	RS1003	Nis
Serbia	RS1009	Novi Knezevac
Slovakia	SK1014	Bratislava
Slovakia	SK1024	Bratislava
Slovakia	SK1015	Roznava
Slovakia	SK1025	Svidnik
Slovakia	SK1026	Zlate Moravce
Spain	ES1047	Barcelona
Spain	ES1012	Madrid
Spain	ES1008	Malaga
Spain	ES1048	Oviedo
Spain	ES1049	Zamora
Ukraine	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	Odessa
Ukraine	UA1032	Odessa
Ukraine	UA1001	Poltava
Ukraine	UA1036	Vinnitsa
United States	US1009	Atlanta	Georgia
United States	US1403	Atlanta	Georgia
United States	US1451	Austin	Texas
United States	US1018	Bellflower	California
United States	US1426	Berlin	New Jersey
United States	US1395	Bradenton	Florida
United States	US1041	Cerritos	California
United States	US1319	Charleston	South Carolina
United States	US1390	Charlotte	North Carolina
United States	US1401	Charlotte	North Carolina
United States	US1046	Chicago	Illinois
United States	US1062	Costa Mesa	California
United States	US1463	Culver City	California
United States	US1065	Dallas	Texas
United States	US1442	Decatur	Georgia
United States	US1086	Flowood	Mississippi
United States	US1443	Fort Worth	Texas
United States	US1104	Garden Grove	California
United States	US1405	Glen Oaks	New York
United States	US1118	Glendale	California
United States	US1441	Hickory	North Carolina
United States	US1423	Hoffman Estates	Illinois
United States	US1253	Jacksonville	Florida
United States	US1244	Jamaica	New York
United States	US1444	Las Vegas	Nevada
United States	US1454	Marlton	New Jersey
United States	US1130	Miami	Florida
United States	US1114	National City	California
United States	US1394	New York	New York
United States	US1416	New York	New York
United States	US1124	Norristown	Pennsylvania
United States	US1129	North Miami	Florida
United States	US1318	North Miami	Florida
United States	US1402	Oakland Park	Florida
United States	US1452	Oceanside	California
United States	US1459	Oceanside	California
United States	US1368	Orange	California
United States	US1399	Orange	California
United States	US1229	Orange City	Florida
United States	US1171	Rochester	New York
United States	US1391	San Bernardino	California
United States	US1464	Santa Ana	California
United States	US1384	Sherman Oaks	California
United States	US1398	Shreveport	Louisiana
United States	US1404	Shreveport	Louisiana
United States	US1190	Staten Island	New York
United States	US1453	Tampa	Florida
United States	US1392	Torrance	California
United States	US1396	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Czechia,  Estonia,  Finland,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From Randomization to Week 10
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.	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.	From Randomization to Week 10
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.	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.	From Randomization to Week 10
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.	From Randomization to Week 10
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.	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.	From Randomization to Week 10