Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
- Registration Number
- NCT03238326
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 295
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Rollover & De-Novo Brexpiprazole 1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
- Primary Outcome Measures
Name Time Method Frequency & Severity of Adverse Events (AE) [Safety] Up to 24 months or early termination with a 21 day follow-up period Frequency and severity will be monitored; along with serious AEs \& discontinuation from trial due to AE
- Secondary Outcome Measures
Name Time Method Change in Abnormal Involuntary Movement Scale (AIMS) Score [Safety] Up to 24 months or early termination Mean change from baseline will be assessed
Change in Children's Global Assessment Scale (CGAS) Score Up to 24 months or early termination Change from baseline in CGAS will be assessed for efficacy of drug
Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests [Safety] Up to 24 months or early termination Abnormalities in hematology, serum chemistry \[including fasting blood lipids, glucose and insulin, serum prolactin\], glycosylated hemoglobin \[HbA1c\], creatine phosphokinase \[CPK\] and urinalysis) results
Mean change from baseline and incidence of clinically significant abnormalities in vital signs [Safety] Up to 24 months or early termination with a 21 day follow-up period Mean change from baseline in supine and standing positions will be assessed and incidence of clinically significant abnormalities
Height [Safety] Up to 24 months or early termination Change in height, in centimeters, will be assessed for any notable differences from baseline
Body Mass Index (BMI) [Safety] Up to 24 months or early termination Measured in kilograms/meter\^2 and assessed to determine any notable differences from baseline
Weight [Safety] Up to 24 months or early termination Change in weight, in kilograms, will be assessed for any notable differences from baseline
Change in Simpson-Angus Scale (SAS) Score [Safety] Up to 24 months or early termination Mean change from baseline will be assessed
The frequency of symptom items from New York Assessment for Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) [Safety] Up to 24 months or early termination Frequency of symptom items will be assessed
Time to discontinuation due to AE Up to 24 months or early termination Time to discontinue will be assessed as applicable
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score and PANSS Subscale Scores Up to 24 months or early termination Change from baseline in total score will be assessed for efficacy of drug. Positive/Negative subscale scores will be assessed for efficacy of drug.
Change in Clinical Global Impression Severity (CGI-S) Score Up to 24 months or early termination Change in Clinical Global Impression Improvement (CGI-I) Score Up to 24 months or early termination Waist Circumference [Safety] Up to 24 months or early termination Change in waist circumference, in centimeters will be assessed for any notable differences from baseline
Changes in ECG [Safety] Up to 24 months or early termination Mean change from baseline will be assessed and incidence of clinically significant abnormalities
Change in Barnes Akathisia Rating Scale (BARS) Score [Safety] Up to 24 months or early termination Mean change from baseline will be assessed
Comprehensive psychotropic side effects as assessed by Udvalg for Kliniske Undersogelser (UKU) [Safety] Up to 24 months or early termination Psychotropic side effects will be assessed by UKU
Potential suicide events recorded on the Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety] Up to 24 months or early termination Analysis of potential suicide events recorded with C SSRS
Change in Tanner Staging Scale Scores [Safety] Up to 24 months or early termination Baseline and post-baseline data will be assessed
Trial Locations
- Locations (57)
Clinical Research Site #272
🇵🇱Poznań, Poland
Clinical Research Site #270
🇵🇱Walbrzych, Poland
Clinical Research Site #267
🇵🇱Wrocław, Poland
Clinical Research Site #244
🇷🇴Bucuresti, Romania
Clinical Research Site #241
🇷🇴Cluj-Napoca, Romania
Clinical Research Site #243
🇷🇴Iaşi, Romania
Clinical Research Site #242
🇷🇴Timişoara, Romania
Clinical Research Site #542
🇷🇺Arkhangel'sk, Primorsky District, Russian Federation
Clinical Research Site #543
🇷🇺Stavropol', Stavropolskiy Kray, Russian Federation
Clinical Research Site #545
🇷🇺Moscow, Russian Federation
Clinical Research Site #541
🇷🇺Saint Petersburg, Russian Federation
Clinical Research Site #101
🇺🇸Dothan, Alabama, United States
Clinical Research Site #161
🇲🇽Culiacán, Sinaloa, Mexico
Clinical Research Site #166
🇲🇽Mérida, Yucatan, Mexico
Clinical Research Site #168
🇲🇽Durango, Mexico
Clinical Research Site #263
🇵🇱Tyniec Mały, Dolnyslask, Poland
Clinical Research Site #128
🇺🇸Anaheim, California, United States
Clinical Research Site #105
🇺🇸Culver City, California, United States
Clinical Research Site #103
🇺🇸Long Beach, California, United States
Clinical Research Site #148
🇺🇸Kansas City, Kansas, United States
Clinical Research Site #266
🇵🇱Białystok, Podlasie, Poland
Clinical Research Site #136
🇺🇸Atlanta, Georgia, United States
Clinical Research Site #138
🇺🇸Lake Charles, Louisiana, United States
Clinical Research Site #124
🇺🇸Las Vegas, Nevada, United States
Clinical Research Site #130
🇺🇸New York, New York, United States
Clinical Research Site #133
🇺🇸Cincinnati, Ohio, United States
Clinical Research Site #100
🇺🇸Rochester, New York, United States
Clinical Research Site #121
🇺🇸Kinston, North Carolina, United States
Clinical Research Site #113
🇺🇸Garfield Heights, Ohio, United States
Clinical Research Site #102
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Site #135
🇺🇸Tulsa, Oklahoma, United States
Clinical Research Site #140
🇺🇸Frisco, Texas, United States
Clinical Research Site #108
🇺🇸Everett, Washington, United States
Clinical Research Site #321
🇫🇷Nice, France
Clinical Research Site #283
🇮🇹Naples, Italy
Clinical Research Site #163
🇲🇽León, Guanajuato, Mexico
Clinical Research Site #165
🇲🇽Guadalajara, Jalisco, Mexico
Clinical Research Site #171
🇲🇽Monterrey, Nuevo Leon, Mexico
Clinical Research Site #160
🇲🇽Monterrey, Nuevo Leon, Mexico
Clinical Research Site #170
🇲🇽San Luis PotosÃ, San Luis Potosi, Mexico
Clinical Research Site #269
🇵🇱Gdańsk, Polorskie, Poland
Clinical Research Site #260
🇵🇱Poznań, Poland
Clinical Research Site #540
🇷🇺Saint Petersburg, Russian Federation
Clinical Research Site #544
🇷🇺Yaroslavl, Russian Federation
Clinical Research Site #500
🇷🇸Belgrade, Serbia
Clinical Research Site #504
🇷🇸Belgrade, Serbia
Clinical Research Site #503
🇷🇸Kragujevac, Serbia
Clinical Research Site #502
🇷🇸Niš, Serbia
Clinical Research Site #501
🇷🇸Novi Sad, Serbia
Clinical Research Site #224
🇪🇸Torremolinos, Malaga, Spain
Clinical Research Site #526
🇺🇦Poltava, Poltava Region, Ukraine
Clinical Research Site #527
🇺🇦Dnipro, Ukraine
Clinical Research Site #523
🇺🇦Kharkiv, Ukraine
Clinical Research Site #521
🇺🇦Kharkiv, Ukraine
Clinical Research Site #522
🇺🇦Kherson, Ukraine
Clinical Research Site #520
🇺🇦Lviv, Ukraine
Clinical Research Site #525
🇺🇦Ternopil', Ukraine