Clinical trial NCT03230864: Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
Official title: Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Treatment-resistant Schizophrenia
Keywords: Treatment-resistant schizophrenia
Lu AF35700
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-07-27
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of 10 mg/day Lu AF35700 on symptoms of schizophrenia in patients with early-in-disease (ED) or late-in-disease (LD) treatment-resistant schizophrenia (TRS)

Detailed description: In the study, patients will receive risperidone (4-6 mg/day), or, if recently failed on risperidone, olanzapine (15-20mg/day). Later during the study, patients will be randomized to either receive Lu AF35700 (10 mg/day), or continue their treatment from the prospective confirmation (PC) period.

The study consists of a Screening Period (up to 3 weeks), a single-blind PC Period (6 weeks), a Double-blind Treatment (DBT) Period (8 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Patients who did not fulfil the randomization criteria for the DBT Period, were withdrawn from the study after the PC period.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 the 2 treatmetn arms (1:1) with either Lu AF35700 10 mg or to continue the treatment allocated in the PC period (olanzapine or risperidone) at the dose set at the last visit of the PC period. This means that approximately half of the confirmed treatment-resistant patients were randomised back to the failed treatment in the PC period.

Data was not collected seperately for the DBT olanzapine and DBT risperidone participants, and there was no intent to compare Lu AF35700 to each drug seperately.

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 (MINI-Schz).
* The patient is receiving treatment with a psychiatrist in either an inpatient or outpatient facility.
* The patient has been treated with adequate dose(s) of antipsychotic drug treatment for at least 2 weeks prior to the Screening Visit.
* The patient has failed to show an adequate response in the level of psychotic symptoms during at least one documented treatment trial with an adequate dose of an antipsychotic drug prescribed for an adequate time (at least lasting for 6 weeks) within 2 years prior to the Screening Visit. The failure to respond to the current antipsychotic drug treatment trial may be considered a retrospective failed treatment, if the patient has been treated for 6 weeks with adequate dose(s) of antipsychotic drug(s).
* The patient has a PANSS total score of ≥80 (on 1-7 scale) and a score of ≥4 (≥ "Moderate" on 1-7 scale) on at least 2 of the following PANSS items at the Screening and at Baseline 1 \[Week 0\] Visits: P2 - Conceptual disorganization, P3 - Hallucinatory behavior, P6 - Suspiciousness/persecution, G9 - Unusual thought content; AND the patient has a CGI-S score of ≥4 (≥ "Moderately ill") at the Screening and at Baseline 1 (Week 0) Visits.

Exclusion Criteria:

* The patient has any current primary psychiatric disorder other than schizophrenia, as assessed using the MINI-Schz.
* The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-5™ criteria).
* The patient is experiencing an acute exacerbation of his/her psychotic symptoms.
* The patient has been treated with, AND is resistant to, clozapine according to the investigator's judgement.

Primary outcomes:
measure: Change From Randomization to Week 8 in Positive and Negative Syndrome Scale (PANSS) Total Score
timeFrame: From Randomization to Week 8
Secondary outcomes:
measure: Change From Randomization to Week 8 in Global Clinical Impression - Severity of Illness (CGI-S) Score
timeFrame: From Randomization to Week 8
measure: Change From Randomization to Week 8 in 16-item Negative Symptom Assessment (NSA-16 Total) Score
timeFrame: From Randomization to Week 8
measure: Change From Randomization to Week 8 in PANSS Marder Negative Factor Score
timeFrame: From Randomization to Week 8
measure: Response
timeFrame: at Week 8
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego Health System
state: California
city: Atlanta
country: United States
facility: Emory University Cognitive Neurology Clinic & ADRC
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Fall River
country: United States
facility: Corrigan Mental Health Center
state: Massachusetts
city: Worcester
country: United States
facility: University Of Massachusetts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Clinical Research Institute PC
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo Community Mental Health and Substance Abuse Services
state: Michigan
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Salt Lake City
country: United States
facility: Psychiatric and Behavioral Solutions
state: Utah
city: Kardzhali
country: Bulgaria
facility: SPH - Kardzhali
city: Novi Iskar
country: Bulgaria
facility: State Psychiatric Hospital
city: Pleven
country: Bulgaria
facility: UMHAT
city: Radnevo
country: Bulgaria
facility: State Psychiatric Hospital
city: Sofia
country: Bulgaria
facility: DCC St. Vrach and St.St. Kuzma and Damian
city: Sofia
country: Bulgaria
facility: MHC - Sofia
city: Tărgovište
country: Bulgaria
facility: MHAT - Targovishte
city: Aizu-Wakamatsu
country: Japan
facility: Takeda General Hospital - JP0009
city: Fukushima
country: Japan
facility: Takeda General Hospital
city: Ichikawa
country: Japan
facility: Kohnodai Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kitakyushu
country: Japan
facility: University of Occupational and Environmental Health Hospital
city: Kita
country: Japan
facility: Sankeikai Nishigahara Hospital - JP0008
city: Kodaira
country: Japan
facility: National Center of Neurology and Psychiatry
city: Kumamoto
country: Japan
facility: Satokai Yuge Hospital
city: Kunigami
country: Japan
facility: NHO Ryukyu Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Ekaterinburg
country: Russian Federation
facility: Sverdlovsk Regional Clinical Psychiatric Hospital
city: Lipetsk
country: Russian Federation
facility: GUZ Lipetsk Regional psychoneurological Hospital 1
city: Lipetsk
country: Russian Federation
facility: Lipetsk Regional Psychoneurological Hospital
city: Saint Petersburg
country: Russian Federation
facility: City Psychiatric Hospital # 6
city: Saint Petersburg
country: Russian Federation
facility: Psychoneurological Dispensary #10
city: Saint Petersburg
country: Russian Federation
facility: Psychoneurological Dispensary #1
city: Samara
country: Russian Federation
facility: Samara Psychiatric Hospital
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Centre of the Russian Academy of Sciences
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional Clinical Psychiatric Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Edinburgh Hospital
city: London
country: United Kingdom
facility: The Maudsley Hospital - GB0001
city: London
country: United Kingdom
facility: The Maudsley Hospital
city: Manchester
country: United Kingdom
facility: Manchester Mental Health & Social Care NHS Trust - GB0003
city: Manchester
country: United Kingdom
facility: Manchester Mental Health & Social Care NHS Trust
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H.Lundbeck A/S
role: STUDY_DIRECTOR
References: