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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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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2005-002979-33-ES |
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Date of registration:
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22/09/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Estudio de la eficacia y seguridad de risperidona en el tratamiento de adolescentes con esquizofrenia: Estudio abierto de seis meses.
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Scientific title:
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Estudio de la eficacia y seguridad de risperidona en el tratamiento de adolescentes con esquizofrenia: Estudio abierto de seis meses. |
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Date of first enrolment:
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19/01/2006 |
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Target sample size:
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120 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002979-33 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Spain
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Key inclusion & exclusion criteria
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Inclusion criteria:
El sujeto y su representante legal deberán haber otorgado su consentimiento informado para participar antes de iniciar los procedimientos de selección;
Sujetos con expectativas en el beneficio del tratamiento mantenido con risperidona;
Los sujetos pueden ser de ambos sexos de 13 a 17 años
Diagnosticados de esquizofrenia de acuerdo a los criterios DSM-IV
Los sujetos deberán tener una puntuación PANSS entre 40 y 120 (inclusive) en la selección y en el periodo basal.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Sujetos que en la selección cumplen los criterios DSM-IV relativos a trastorno disociativo, trastorno bipolar, trastorno depresivo mayor, trastorno esquizoafectivo, trastorno esquizofreniforme, trastorno autista o trastorno psicótico primario inducido por sustancias.
Sujetos que el investigador considera en riesgo significativo de suicidio o conducta violenta
Sujetos cuyo Índice de Masa Corporal (BMI) es inferior al percentil 5º o superior al percentil 95º.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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SCHIZOPHRENIA/ Adolescents
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Intervention(s)
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Trade Name: Risperdal1 mg
Product Name: Risperdal 1mg
Product Code: F5
Pharmaceutical Form: Tablet
INN or Proposed INN: risperidone
Current Sponsor code: R064766
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Main Objective: Valorar la eficacia y seguridad de risperidona a lo largo de 6 meses de tratamiento en adolescentes con esquizofrenia
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Primary end point(s): Cambio en la puntuación PANSS
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Secondary Objective:
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Secondary ID(s)
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RIS-USA-234
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/11/2005
Contact:
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