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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00320671 |
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Date of registration:
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01/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Aripiprazole and Risperidone for the Treatment of People With First-Episode Psychosis
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Scientific title:
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Preventing Morbidity in First Episode Schizophrenia, Part II |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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198 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00320671 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Delbert Robinson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The North Shore-Long Island Jewish Health System |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis of
schizophrenia, schizophreniform disorder, schizoaffective disorder, or similar
psychotic disorder not otherwise specified, as assessed using the Structured Clinical
Interview for Axis I DSM-IV Disorders (SCID-I/P)
- History of previous antipsychotic medication treatment for a duration of 2 weeks or
less
- Current positive symptoms rated 4 (moderate) or more on one or more of the following
Brief Psychiatric Rating Scale (BPRS-A) items: conceptual disorganization;
grandiosity; hallucinatory behavior; or unusual thought content
- Agrees to use an effective form of contraception
Exclusion Criteria:
- Any serious neurological or endocrine disorder, or any medical condition or treatment
known to affect the brain
- Any current medical condition that requires treatment with a medication with
psychotropic effects
- At significant risk for suicidal or homicidal behavior
- Cognitive or language limitations, or any other factor that would interfere with a
participant's ability to provide informed consent or safely participate in study
procedures
- Diagnosis of diabetes, defined as a fasting plasma glucose level of at least 126
mg/dL, or metabolic syndrome, defined as three or more of the following: high blood
pressure (greater than 135/85 mmHg); truncal obesity (having a waist circumference
greater than 40 inches for men and greater than 35 inches for women); elevated fasting
glucose (greater than 110 mg/dL); low HDL-cholesterol (less than 40 mg/dL for men and
less than 50 mg/dL for women); or elevated triglycerides (defined as greater than 150
mg/dL)
- Requires treatment with an antidepressant or mood stabilizing medication
- Meets DSM-IV criteria for a current substance-induced psychotic disorder, a psychotic
disorder due to a general medical condition, delusional disorder, brief psychotic
disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar)
with psychotic features
- Any medical conditions that would make treatment with risperidone or aripiprazole
medically inadvisable
Age minimum:
15 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Drug: Risperidone
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Drug: Aripiprazole
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Primary Outcome(s)
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Percentage of Participants That Responded to Treatment
[Time Frame: this outcome was assessed throughout the study.]
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Secondary ID(s)
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R01MH060004-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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