- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00095134
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
A Double-Blind Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Many patients who suffer from Major Depressive Disorder (MDD) do not benefit or show only partial benefit from current psychotropic therapy. This clinical trial seeks to study the efficacy and safety of adjunctive treatment with risperidone in patients with MDD who failed to adequately respond to standard antidepressant treatment prior to this trial and who prospectively do not respond to adequate treatment with standard antidepressant therapy (SAD).
Patients entering the open label phase of the study will have already taken a commercially available SAD for a minimum of 4 weeks, and provided the dose was optimal, will continue on this dose of SAD throughout the four-week open-label and six-week double-blind phases of the trial.
If the dose in the four weeks prior to entering the study was not optimal (as per standard clinical practice), the dose will be increased to be within the optimal range and continued at that dose through the entire open-label SAD and double-blind phases.
During the double-blind phase, subjects receive an adjunctive dose of risperidone or placebo, once daily, added to their stable dose of SAD. The starting dose of risperidone or placebo is 0.25 mg for the first three days of the double-blind phase, and is increased to 0.5 mg for days 4 through 14. On the 15th day of this phase, the dose is increased to the target dose of 1.0 mg/day. If response to this dose is not optimal by day 29, it is increased to 2.0 mg/day and is maintained for the duration of the 6-week double-blind phase. This dose may be reduced once to 1.0 mg/day, but then must be maintained at that dose for the remainder of the study.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- Innovative Clinical Trials, LLC
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Birmingham, Alabama, Estados Unidos, 35242
- Greystone Medical Research
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85251
- Scottsdale Family Health
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Sun City, Arizona, Estados Unidos, 85351
- Sun Valley Medical
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Tucson, Arizona, Estados Unidos, 85711
- Southwest Biomedical Research Foundation
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California
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Burbank, California, Estados Unidos, 91506
- Southwestern Research Institute
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Inglewood, California, Estados Unidos, 90301
- Chrishard Clinical Research
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La Mesa, California, Estados Unidos, 91942
- Optimum Health Services
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Los Angeles, California, Estados Unidos, 90024
- Pacific Insititute for Medical Research
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Oceanside, California, Estados Unidos, 92056
- Optimum Health Services
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Riverside, California, Estados Unidos, 92506
- Behavioral Health 2000, LLC
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San Diego, California, Estados Unidos, 92103
- nTouch Research
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Connecticut
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New London, Connecticut, Estados Unidos, 06320
- Psychiatric Medicine Center
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Delaware
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Newark, Delaware, Estados Unidos, 19702
- Glasgow Family Practice
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Florida
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Ft. Lauderdale, Florida, Estados Unidos, 33311
- Leonard Bass, MD, PA
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Gainesville, Florida, Estados Unidos, 32607
- Sarkis Clinical Trials
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Jacksonville, Florida, Estados Unidos, 32257
- Roger Miller, MD
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North Miami, Florida, Estados Unidos, 33161
- BioQuan Research Group, Inc.
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St. Cloud, Florida, Estados Unidos, 34769
- Family Practice - St. Cloud
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Illinois
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Arlington Heights, Illinois, Estados Unidos, 60005
- Allan B. Aven, MD
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Naperville, Illinois, Estados Unidos, 60542
- nTouch Research - Chicago
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Peoria, Illinois, Estados Unidos, 61614
- Balanced Health Research Center
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Peoria, Illinois, Estados Unidos, 61602
- nTouch Research - Peoria
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Indiana
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Avon, Indiana, Estados Unidos, 46123
- American Health Network
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Evansville, Indiana, Estados Unidos, 47714
- Research Solutions - Evansville
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Indianapolis, Indiana, Estados Unidos, 46260
- Amy Kaissar, MD
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Terre Haute, Indiana, Estados Unidos, 47802
- Clinco
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Kentucky
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Florence, Kentucky, Estados Unidos, 41042
- Hartford Research Group
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70001
- New Orleans Medical Institute
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Shreveport, Louisiana, Estados Unidos, 71101
- Brentwood Research Institute
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Michigan
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Cadillac, Michigan, Estados Unidos, 49601
- Professional Clinical Research at Great Lakes Family Care
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Missouri
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St. Louis, Missouri, Estados Unidos, 63125
- Sam Hawatmeh, MD, PC
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Nebraska
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Alliance, Nebraska, Estados Unidos, 69301
- Alliance Medical Center, PC
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New Jersey
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Glendora, New Jersey, Estados Unidos, 08029
- Clinical Trial Associates
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Turnersville, New Jersey, Estados Unidos, 08012
- Partners in Primary Care
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 81709
- ABQ Med., P.C.
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New York
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New York, New York, Estados Unidos, 10021
- Eastside Comprehensive Medical Services, LLC
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North Carolina
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Raleigh, North Carolina, Estados Unidos, 27609
- Raleigh Medical Group
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Winston Salem, North Carolina, Estados Unidos, 27103
- Salem Research Group
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Ohio
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Canal Fulton, Ohio, Estados Unidos, 44614
- Community Health Care, Inc.
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Cincinnati, Ohio, Estados Unidos, 45224
- Hightop Medical Research Center
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Cincinnati, Ohio, Estados Unidos, 45242
- CFP Research, Inc.
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Cincinnati, Ohio, Estados Unidos, 45219
- Community Research Management Associates, Inc.
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Dayton, Ohio, Estados Unidos, 45406
- Martin Schear, MD
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Wadsworth, Ohio, Estados Unidos, 44281
- Family Practice Center of Wadsworth
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Oklahoma
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Edmond, Oklahoma, Estados Unidos, 73013
- Sooner Clinical Research
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Moore, Oklahoma, Estados Unidos, 73160
- Med-line Research
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Cutting Edge Research Group
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Oregon
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Eugene, Oregon, Estados Unidos, 97401
- Advanced Clinical Trials
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Medford, Oregon, Estados Unidos, 97504
- Medford Medical Clinic, LLP
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Medford, Oregon, Estados Unidos, 97504
- Clinical Research Consultants/Providence Medical
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Pennsylvania
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Downingtown, Pennsylvania, Estados Unidos, 19335
- Gateway Medical
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Feasterville, Pennsylvania, Estados Unidos, 19053
- Feasterville Family Health Care
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Lansdale, Pennsylvania, Estados Unidos, 19446
- Detweiler Family Medicine
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Lansdale, Pennsylvania, Estados Unidos, 19466
- Green & Seidner Family Practice
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Levittown, Pennsylvania, Estados Unidos, 19057
- Woodburne Family Practice
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Norristown, Pennsylvania, Estados Unidos, 19401
- Pearl Clinical Research
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Philadelphia, Pennsylvania, Estados Unidos, 19152
- Joseph Rybicki, MD
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Pittsburgh, Pennsylvania, Estados Unidos, 15206
- Clinical Trials Research Services, LLC
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Pittsburgh, Pennsylvania, Estados Unidos, 15221
- Consolidated Clinical Trials, Inc.
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Pottstown, Pennsylvania, Estados Unidos, 19465
- Charles Buttz, MD
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Reading, Pennsylvania, Estados Unidos, 19606
- Research Across America
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South Carolina
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Greer, South Carolina, Estados Unidos, 29651
- The Family Practice
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Tennessee
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Johnson City, Tennessee, Estados Unidos, 37601
- Harmony Clinical Research
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Texas
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Beaumont, Texas, Estados Unidos, 77701
- DiscoveResearch, Inc.
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Corpus Christi, Texas, Estados Unidos, 78411
- South Texas Applied Research
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Virginia
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Richmond, Virginia, Estados Unidos, 23294
- International Clinical Research Associates, LLC
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Virgina Beach, Virginia, Estados Unidos, 23452
- International Clinical Research Associates
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Washington
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Kirkland, Washington, Estados Unidos, 98034
- Richard Neiman, MD
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Spokane, Washington, Estados Unidos, 99216
- Daniel Blizzard, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Understand and sign the informed consent form
- Age 18-65
- Healthy on the basis of Physical Exam
- Treatment with a single antidepressant 4 weeks prior to study start and willingness to maintain on stable dose of the same antidepressant throughout the study
- Current diagnosis of Major Depressive Disorder
- Judgement of the clinician that the subject has shown a sub-optimal response to the antidepressant
Exclusion Criteria:
- Presence of other serious medical illness(es)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.
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Medidas de resultado secundarias
Medida de resultado |
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Safety will be assessed through reported adverse events and vital signs (weight, blood pressure, pulse, and temperature).
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Colaboradores e Investigadores
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Pandina G, Turkoz I, Bossie C. Impact of self-reported juvenile abuse on treatment outcome in patients with major depressive disorder. J Affect Disord. 2013 Oct;151(1):384-91. doi: 10.1016/j.jad.2013.01.053. Epub 2013 Jul 10.
- Mahmoud RA, Pandina GJ, Turkoz I, Kosik-Gonzalez C, Canuso CM, Kujawa MJ, Gharabawi-Garibaldi GM. Risperidone for treatment-refractory major depressive disorder: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):593-602. doi: 10.7326/0003-4819-147-9-200711060-00003.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Trastornos del estado de ánimo
- Depresión
- Desorden depresivo
- Trastorno Depresivo Mayor
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Agentes de serotonina
- Agentes de dopamina
- Antagonistas de serotonina
- Antagonistas de la dopamina
- Risperidona
Otros números de identificación del estudio
- CR004726
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .