This study will determine the efficacy of oral risperidone (Risperdal) versus long-acting
injectable paliperidone palmitate (Invega Sustenna) in treating people with first-episode
Drug: paliperidone palmitate
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Locations near you
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Full eligibility criteria for NCT01451736
Ages eligible for Study
18 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
1. A first episode of a psychotic illness is occurring or did occur within the last 2
2. A diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth
Edition(DSM-IV)of schizophrenia, schizoaffective disorder, depressed type, or
schizophreniform disorder; and
3. Between 18 and 45 years of age.
1. Neurological disorder (e.g., epilepsy) or significant head injury;
2. Significant alcohol or substance use disorder within the six months prior to the first
episode and evidence that substance abuse triggered the psychotic episode or makes the
schizophrenia diagnosis ambiguous;
3. Mental retardation, i.e. premorbid intelligence quotient (IQ) less than 70;
4. Insufficient acculturation and fluency in the English language to avoid invalidating
research measures of thought, language, and speech disorder or of verbal abilities;
5. Residence likely to be outside of commuting distance of the University of California,
Los Angeles (UCLA) Aftercare Research Program; or
6. Patient has shown an inadequate response to an adequate previous trial of oral or
long-acting injectable risperidone, paliperidone, or paliperidone palmitate.
All locations for NCT01451736
United States (1)
UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States, 90095
View full eligibility
Tris trial is registered with FDA with number: NCT01451736. The sponsor of the trial is University of California, Los Angeles and it is looking for 170 volunteers for the current phase.
Official trial title: Clinical and Cognitive Effects of Paliperidone Palmitate vs. Oral Risperidone in First-Episode Schizophrenia
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