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SchizophreniaPhase 3DayBreakNCT02717195

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

A Phase 3 study testing Risperidone, Olanzapine and Lu AF35700 in people with Schizophrenia, run by H. Lundbeck A/S at 147 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Risperidone, Olanzapine and Lu AF35700
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,098 participants
Where
147 sitesin 14 countries
Study dates
Apr 2016to 8 Oct 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

147 sites in 14 countries.

147 sites in 14 countries

United States49 sites

  • US1403

    Atlanta, Georgia, 30328

  • US1009

    Atlanta, Georgia, 30331

  • US1451

    Austin, Texas, 78754-5122

  • US1018

    Bellflower, California, 90706

  • US1426

    Berlin, New Jersey, 08009

  • US1395

    Bradenton, Florida, 32751

  • US1041

    Cerritos, California, 90703

  • US1319

    Charleston, South Carolina, 29407

  • US1390

    Charlotte, North Carolina, 28204-3110

  • US1401

    Charlotte, North Carolina, 28211-1064

  • US1046

    Chicago, Illinois, 60640

  • US1062

    Costa Mesa, California, 92626

  • US1463

    Culver City, California, 90230

  • US1065

    Dallas, Texas, 75243

  • US1442

    Decatur, Georgia, 30030

  • US1086

    Flowood, Mississippi, 39232

  • US1443

    Fort Worth, Texas, 76104

  • US1104

    Garden Grove, California, 92845

  • US1405

    Glen Oaks, New York, 11004

  • US1118

    Glendale, California, 91206

  • US1441

    Hickory, North Carolina, 28601-5045

  • US1423

    Hoffman Estates, Illinois, 60169-1067

  • US1253

    Jacksonville, Florida, 32256

  • US1244

    Jamaica, New York, 11432

  • US1444

    Las Vegas, Nevada, 89102-1943

  • US1454

    Marlton, New Jersey, 08053

  • US1130

    Miami, Florida, 33122

  • US1114

    National City, California, 91950

  • US1394

    New York, New York, 10032

  • US1416

    New York, New York, 10035-6000

  • US1124

    Norristown, Pennsylvania, 19403

  • US1318

    North Miami, Florida, 33161

  • US1129

    North Miami, Florida, 33162

  • US1402

    Oakland Park, Florida, 33334-4400

  • US1452

    Oceanside, California, 92056-4509

  • US1459

    Oceanside, California, 92056-4515

  • US1399

    Orange, California, 91945

  • US1368

    Orange, California, 92868

  • US1229

    Orange City, Florida, 32763

  • US1171

    Rochester, New York, 14618

  • US1391

    San Bernardino, California, 92408-3332

  • US1464

    Santa Ana, California, 92705-3610

  • US1384

    Sherman Oaks, California, 91403-1747

  • US1398

    Shreveport, Louisiana, 71101-4603

  • US1404

    Shreveport, Louisiana, 71104-2136

  • US1190

    Staten Island, New York, 10312

  • US1453

    Tampa, Florida, 33609-2231

  • US1392

    Torrance, California, 90502-4432

  • US1396

    Washington D.C., District of Columbia, 20016

Other trials in United States

Russia14 sites

  • RU1009

    Arkhangelsk

  • RU1006

    Moscow

  • RU1051

    Moscow

  • RU1055

    Moscow

  • RU1021

    Nikol’skoye, Gatchinckiy District

  • RU1023

    Saint Petersburg

  • RU1028

    Saint Petersburg

  • RU1030

    Saint Petersburg

  • RU1031

    Saint Petersburg

  • RU1049

    Saint Petersburg

  • RU1052

    Saint Petersburg

  • RU1053

    Saint Petersburg

  • RU1056

    Saint Petersburg

  • RU1050

    Yaroslavl

Other trials in Russia

Ukraine14 sites

  • UA1019

    Dnipropetrovsk

  • UA1017

    Kharkiv

  • UA1022

    Kharkiv

  • UA1031

    Kharkiv

  • UA1035

    Kharkiv

  • UA1028

    Kherson

  • UA1029

    Kherson

  • UA1027

    Kiev

  • UA1030

    Kiev

  • UA1033

    Lviv

  • UA1020

    Odesa

  • UA1032

    Odesa

  • UA1001

    Poltava

  • UA1036

    Vinnitsa

Other trials in Ukraine

Bulgaria12 sites

  • BG1030

    Burgas

  • BG1028

    Kazanlak

  • BG1003

    Lovech

  • BG1032

    Pazardzhik

  • BG1008

    Plovdiv

  • BG1024

    Sofia

  • BG1026

    Sofia

  • BG1022

    Tserova Koria

  • BG1033

    Varna

  • BG1034

    Varna

  • BG1029

    Veliko Tarnovo

  • BG1027

    Vratsa

Other trials in Bulgaria

Mexico10 sites

  • MX1024

    Durango

  • MX1011

    Guadalajara

  • MX1021

    Guadalajara

  • MX1022

    Guadalajara

  • MX1020

    México

  • MX1005

    Monterrey

  • MX1007

    Monterrey

  • MX1015

    Monterrey

  • MX1016

    Monterrey

  • MX1018

    San Luis Potosí City

Other trials in Mexico

Poland9 sites

  • PL1025

    Bełchatów

  • PL1043

    Bialystok

  • PL1026

    Gorlice

  • PL1060

    Lodz

  • PL1027

    Lublin

  • PL1058

    Pruszcz Gdański

  • PL1061

    Pruszków

  • PL1059

    Torun

  • PL1051

    Wroclaw

Other trials in Poland

Serbia8 sites

  • RS1008

    Belgrade

  • RS1010

    Belgrade

  • RS1012

    Belgrade

  • RS1011

    Kragujevac

  • RS1016

    Kragujevac

  • RS1017

    Kragujevac

  • RS1003

    Niš

  • RS1009

    Novi Kneževac

Other trials in Serbia

Canada6 sites

  • CA1017

    Chatham

  • CA1034

    Kingston

  • CA1003

    Montreal

  • CA1033

    Montreal

  • CA1029

    Penticton

  • CA1039

    Québec

Other trials in Canada

Czechia5 sites

  • CZ1023

    Brno

  • CZ1032

    Brno

  • CZ1037

    Hostivice

  • CZ1013

    Lnáře

  • CZ1038

    Prague

Other trials in Czechia

Slovakia5 sites

  • SK1014

    Bratislava

  • SK1024

    Bratislava

  • SK1015

    Rožňava

  • SK1025

    Svidník

  • SK1026

    Zlaté Moravce

Other trials in Slovakia

Spain5 sites

  • ES1047

    Barcelona

  • ES1012

    Madrid

  • ES1008

    Málaga

  • ES1048

    Oviedo

  • ES1049

    Zamora

Other trials in Spain

Romania4 sites

  • RO1024

    Bucharest

  • RO1022

    Campulung Muscel

  • RO1025

    Sibiu

  • RO1004

    Târgu Mureş

Other trials in Romania

Estonia3 sites

  • EE1016

    Pärnu

  • EE1007

    Tallinn

  • EE1017

    Viljandi

Other trials in Estonia

Finland3 sites

  • FI1032

    Espoo

  • FI1030

    Kuopio

  • FI1027

    Turku

Other trials in Finland

About this study

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

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

Read the 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.

Conditions
Schizophrenia
Being tested
Risperidone, Olanzapine, Lu AF35700
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RisperidoneDrug

    4-6 mg/day, encapsulated tablets, orally

  • OlanzapineDrug

    15-20 mg/day, encapsulated tablets, orally

  • Lu AF35700Drug

    10 mg/day, encapsulated tablets, orally

  • Lu AF35700Drug

    20 mg/day, encapsulated tablets, orally

Study groups in NCT02717195
Study groupRoleWhat they receive
Prospective Confirmation (PC) PeriodExperimentalSingle (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Receives: Drug: Risperidone; Drug: Olanzapine
Double-blind Treatment (DBT) Period, Lu AF35700 10 mgExperimentalEligible 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
Receives: Drug: Lu AF35700
DBT Period, Lu AF35700 20 mgExperimentalEligible 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
Receives: Drug: Lu AF35700
DBT Period, Continued treatment from PC PeriodExperimentalEligible 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
Receives: Drug: Risperidone; Drug: Olanzapine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From Randomization to Week 10

Secondary outcomes (7)

  1. 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.

    Measured: From Randomization to Week 10

  2. 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.

    Measured: From Randomization to Week 10

  3. 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.

    Measured: From Randomization to Week 10

  4. 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.

    Measured: From Randomization to Week 10

  5. 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.

    Measured: From Randomization to Week 10

  6. 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.

    Measured: From Randomization to Week 10

  7. 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.

    Measured: From Randomization to Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion30 Aug 2018
  4. Study completion8 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,098 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02717195
Sponsor's protocol ID
16159A
Other IDs
2014-003569-12, 2014
Acronym
DayBreak
Status last verified
Oct 2019
First submitted
11 Mar 2016
Last updated
25 Nov 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 36115192

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risperidone, Olanzapine and Lu AF35700 in people with Schizophrenia, run by H. Lundbeck A/S at 147 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Russia, Ukraine, Bulgaria, Mexico and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: From Randomization to Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02717195, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.

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