Clinical trial NCT03238326: Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
Official title: A Long-term, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Flexible-Dose Brexpiprazole as Maintenance Treatment in Adolescents (13-17 Years Old) With Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Brexpiprazole
Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2017-08-03
Enrollment: 295
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Detailed description: This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Eligibility criteria: Inclusion Criteria:

* Male \& female subjects 13-17 years of age, inclusive.
* Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
* Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
* Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).

Exclusion Criteria:

* Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
* Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
* History of failure of clozapine treatment or response to clozapine treatment only.
* History of neuroleptic malignant syndrome

Primary outcomes:
measure: Frequency & Severity of Adverse Events (AE) [Safety]
timeFrame: Up to 24 months or early termination with a 21 day follow-up period
Secondary outcomes:
measure: Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety]
timeFrame: Up to 24 months or early termination
measure: Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety]
timeFrame: Up to 24 months or early termination with a 21 day follow-up period
measure: Weight [Safety]
timeFrame: Up to 24 months or early termination
measure: Height [Safety]
timeFrame: Up to 24 months or early termination
measure: Body Mass Index (BMI) [Safety]
timeFrame: Up to 24 months or early termination
measure: Waist Circumference [Safety]
timeFrame: Up to 24 months or early termination
measure: Changes in ECG [Safety]
timeFrame: Up to 24 months or early termination
measure: Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety]
timeFrame: Up to 24 months or early termination
measure: Change in Simpson-Angus Scale (SAS) Score [Safety]
timeFrame: Up to 24 months or early termination
measure: Change in Barnes Akathisia Rating Scale (BARS) Score [Safety]
timeFrame: Up to 24 months or early termination
measure: Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
timeFrame: Up to 24 months or early termination
measure: Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety]
timeFrame: Up to 24 months or early termination
measure: The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety]
timeFrame: Up to 24 months or early termination
measure: Change in Tanner Staging Scale Scores [Safety]
timeFrame: Up to 24 months or early termination
measure: Time to discontinuation due to AE
timeFrame: Up to 24 months or early termination
measure: Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores
timeFrame: Up to 24 months or early termination
measure: Change in Children's Global Assessment Scale (CGAS) Score
timeFrame: Up to 24 months or early termination
measure: Change in Clinical Global Impression Severity (CGI-S) Score
timeFrame: Up to 24 months or early termination
measure: Change in Clinical Global Impression Improvement (CGI-I) Score
timeFrame: Up to 24 months or early termination
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Clinical Research Site #101
state: Alabama
city: Anaheim
country: United States
facility: Clinical Research Site #128
state: California
city: Culver City
country: United States
facility: Clinical Research Site #105
state: California
city: Long Beach
country: United States
facility: Clinical Research Site #103
state: California
city: Atlanta
country: United States
facility: Clinical Research Site #136
state: Georgia
city: Kansas City
country: United States
facility: Clinical Research Site #148
state: Kansas
city: Lake Charles
country: United States
facility: Clinical Research Site #138
state: Louisiana
city: Las Vegas
country: United States
facility: Clinical Research Site #124
state: Nevada
city: New York
country: United States
facility: Clinical Research Site #130
state: New York
city: Rochester
country: United States
facility: Clinical Research Site #100
state: New York
city: Kinston
country: United States
facility: Clinical Research Site #121
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Site #133
state: Ohio
city: Garfield Heights
country: United States
facility: Clinical Research Site #113
state: Ohio
city: Oklahoma City
country: United States
facility: Clinical Research Site #102
state: Oklahoma
city: Tulsa
country: United States
facility: Clinical Research Site #135
state: Oklahoma
city: Frisco
country: United States
facility: Clinical Research Site #140
state: Texas
city: Everett
country: United States
facility: Clinical Research Site #108
state: Washington
city: Nice
country: France
facility: Clinical Research Site #321
city: Naples
country: Italy
facility: Clinical Research Site #283
city: León
country: Mexico
facility: Clinical Research Site #163
state: Guanajuato
city: Guadalajara
country: Mexico
facility: Clinical Research Site #165
state: Jalisco
city: Monterrey
country: Mexico
facility: Clinical Research Site #171
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Clinical Research Site #160
state: Nuevo Leon
city: San Luis Potosí
country: Mexico
facility: Clinical Research Site #170
state: San Luis Potosi
city: Culiacán
country: Mexico
facility: Clinical Research Site #161
state: Sinaloa
city: Mérida
country: Mexico
facility: Clinical Research Site #166
state: Yucatan
city: Durango
country: Mexico
facility: Clinical Research Site #168
city: Tyniec Mały
country: Poland
facility: Clinical Research Site #263
state: Dolnyslask
city: Białystok
country: Poland
facility: Clinical Research Site #266
state: Podlasie
city: Gdańsk
country: Poland
facility: Clinical Research Site #269
state: Polorskie
city: Poznań
country: Poland
facility: Clinical Research Site #260
city: Poznań
country: Poland
facility: Clinical Research Site #272
city: Walbrzych
country: Poland
facility: Clinical Research Site #270
city: Wrocław
country: Poland
facility: Clinical Research Site #267
city: Bucuresti
country: Romania
facility: Clinical Research Site #244
city: Cluj-Napoca
country: Romania
facility: Clinical Research Site #241
city: Iaşi
country: Romania
facility: Clinical Research Site #243
city: Timişoara
country: Romania
facility: Clinical Research Site #242
city: Arkhangel'sk
country: Russian Federation
facility: Clinical Research Site #542
state: Primorsky District
city: Stavropol'
country: Russian Federation
facility: Clinical Research Site #543
state: Stavropolskiy Kray
city: Moscow
country: Russian Federation
facility: Clinical Research Site #545
city: Saint Petersburg
country: Russian Federation
facility: Clinical Research Site #541
city: Saint Petersburg
country: Russian Federation
facility: Clinical Research Site #540
city: Yaroslavl
country: Russian Federation
facility: Clinical Research Site #544
city: Belgrade
country: Serbia
facility: Clinical Research Site #500
city: Belgrade
country: Serbia
facility: Clinical Research Site #504
city: Kragujevac
country: Serbia
facility: Clinical Research Site #503
city: Niš
country: Serbia
facility: Clinical Research Site #502
city: Novi Sad
country: Serbia
facility: Clinical Research Site #501
city: Torremolinos
country: Spain
facility: Clinical Research Site #224
state: Malaga
city: Poltava
country: Ukraine
facility: Clinical Research Site #526
state: Poltava Region
city: Dnipro
country: Ukraine
facility: Clinical Research Site #527
city: Kharkiv
country: Ukraine
facility: Clinical Research Site #523
city: Kharkiv
country: Ukraine
facility: Clinical Research Site #521
city: Kherson
country: Ukraine
facility: Clinical Research Site #522
city: Lviv
country: Ukraine
facility: Clinical Research Site #520
city: Ternopil'
country: Ukraine
facility: Clinical Research Site #525
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Heather Guthrie, MD
role: STUDY_DIRECTOR
References: