Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia



Status:Recruiting
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:13 - 17
Updated:3/13/2019
Start Date:June 30, 2017
End Date:April 2020

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A Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial to Evaluate the Efficacy of Brexpiprazole Monotherapy for the Treatment in Adolescents (13-17 Years Old) With Schizophrenia

To determine the safety & efficacy of brexpiprazole monotherapy in the treatment of
adolescents with schizophrenia.

This is a multicenter, randomized, double-blind, placebo- and active-controlled trial to
evaluate the safety and efficacy of brexpiprazole monotherapy compared to placebo in
adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Inclusion Criteria:

- Male & female subjects aged 13-17 years, inclusive at time of consent and at baseline
visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and
confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to
screening.

- PANSS score >= 80, inclusive, at screening and baseline

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 who have been hospitalized > 21 days for a current exacerbation of
schizophrenia at the time of baseline.

- Any neurological disorder other than Tourette's Syndrome

- Subjects at significant risk of committing violent acts, serious self-harm or suicide
based on history

- Subjects with epilepsy, a history of seizures, severe head trauma or stroke

- Subjects who test positive for drugs of abuse at screening
We found this trial at
22
sites
Culver City, California 90230
Phone: 424-227-8127
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Arlington, Texas 76006
Phone: 214-603-8173
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2150 Peachford Road
Atlanta, Georgia 30338
Phone: 770-458-0447
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Austin, Texas 78759
Phone: 512-382-6661
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Belgrade, 11000
Phone: 381 65 3135 060
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Charlotte, North Carolina 28204
Phone: 980-209-9784
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2068 Orange Tree Lane
Colton, California 92374
Phone: 909-423-0367
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Dothan, Alabama 36303
Phone: 334-836-2000
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830 6th Street South
Everett, Washington 98201
Phone: 425-443-9551
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Garfield Heights, Ohio 44125
Phone: 216-587-6727
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Hartford, Connecticut 06106
Phone: 860-545-7476
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Hialeah, Florida 33012
Phone: 786-536-4177
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4160 West 16th Avenue
Hialeah, Florida 33012
Phone: 305-821-3944
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Houston, Texas 17115
Phone: 281-893-4111
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755 East Flamingo Road
Las Vegas, Nevada 89102
Phone: 702-629-7490
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Long Beach, California 90807
Phone: 562-548-8500
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Neptune, New Jersey 07754
Phone: 732-776-2953
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New York, New York 10022
Phone: 646-678-4196
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Oklahoma City, Oklahoma 73116
Phone: 405-603-8068
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Oklahoma City, Oklahoma 73112
Phone: 405-759-4121
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Rochester, New York 14618
Phone: 585-241-9670
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West Chester, Ohio 45069
Phone: 513-229-7585
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