An Adaptive Treatment Strategy for Adolescent Depression (PTAD)
10 de julio de 2019 actualizado por: University of Minnesota
The purpose of the study is:
- to find out how long teenagers getting talk therapy (interpersonal psychotherapy) for depression should get therapy before the therapist decides whether or not the teenager is improving enough, and
- to compare two ways of providing treatment to teenagers who have not improved enough.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Study Procedures
This study has three phases:
The screening and eligibility phase:
Parent and child will conduct an initial evaluation that will last about 4 hours. The evaluator will ask questions and the participant will complete forms about his/her mood and behavior. This intake appointment will determine eligibility for the study.
The treatment phase: The child would begin a kind of talk therapy called interpersonal psychotherapy. The goal of the therapy is to decrease teenagers' depression by helping them improve their relationships and communication skills. The child will attend 12 therapy appointments over the course of 16 weeks. Each appointment will be 50 minutes long.
If the child is doing well with standard interpersonal therapy, it will be continued without change. If the child has not improved enough, we will change the treatment plan in one of two ways. The choice will be based on chance (sort of like flipping a coin) and will be done by a computer.
***Your child will attend 16 therapy appointments (that is four additional sessions). These additional four sessions will be scheduled so that your child will attend therapy twice a week for a period of four weeks.
-OR-
***Your child will continue to attend 12 therapy appointments over the course of 16 weeks and your child will also be prescribed an antidepressant medication called fluoxetine. Fluoxetine is also known as Prozac. Prozac has been approved by the Food and Drug Administration for use in the treatment of depressed teenagers. You will be responsible for paying for the medication.
At four points during the treatment phase (week 4, week 8, week 12, and week 16), parent and child will be asked to complete forms and interviews to see how the child is doing. The evaluations at weeks 4, 8, and 12 will take approximately 1 hour. At the end of treatment, parent and child will have a longer meeting with the evaluator (4 hours) to see if the treatment your child got was helpful. During these meetings, we will also ask participants to fill out some forms about your mood and mental health treatment.
- The follow-up phase: Parent and child will be asked to return for a follow-up assessment 4 months after the child completes the treatment phase to see how he or she is doing. Parent and child will be asked to complete forms and interviews. This meeting will take approximately 4 hours.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55454
- University of Minnesota, Department of Psychiatry
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Adolescent meets DSM-IV-TR criteria for a diagnosis of Major Depressive Disorder, Dysthymia, or Depressive Disorder NOS; demonstrate symptoms of depression (CDRS-R > 35); and demonstrate impairment in general functioning (CGAS < 65).
- Adolescents and parents must be English-speaking
Exclusion Criteria:
- Adolescent meets criteria for a diagnosis of Schizophrenia, Bipolar Disorder, Psychosis, Substance Abuse, OCD, Conduct Disorder, Eating Disorder, PDD, or intellectual disability disorder.
- Depressed adolescents who are actively suicidal with a plan and/or intent
- Adolescent that are already receiving treatment for depression or if they are taking medication for a psychiatric diagnosis other than ADHD. Depressed adolescents with a comorbid diagnosis of ADHD who are on a stable dose of stimulant medication (> 3 months) will be eligible to participate in the studies.
- Adolescent that have already received an adequate trial of IPT-A or fluoxetine.
- Female adolescents who are pregnant, breastfeeding, or having unprotected sexual intercourse.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Talk Therapy 4-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
After 4 weeks of therapy, participants with at less than a 20% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy frequency or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks.
If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy
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If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy.
Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks.
The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks.
If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day.
Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.
If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.
Otros nombres:
If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.
If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.
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|
Experimental: Talk Therapy 8-Week Decision Point
Interpersonal psychotherapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
After 8 weeks of therapy, participants with at less than a 40% reduction in Hamilton Rating Scale for Depression (HRSD) score will be further randomized into 2 groups, increased dose of interpersonal psychotherapy or introduction of fluoxetine therapy starting with 10 mg per day for the first week and 20 mg per day in the following 5 weeks.
If HRSD scores meet target, patients continue to receive initial dose of interpersonal psychotherapy.
|
If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy.
Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks.
The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks.
If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day.
Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter.
If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.
Otros nombres:
If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.
If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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CDRS-R Score
Periodo de tiempo: Baseline and 16-weeks
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The CDRS-R is a clinician-administered semi-structured interview that assesses symptoms of depression experienced during the previous 2-weeks.
The first 14 items are rated on the basis of an interview.
The remaining 3 items are rated by a clinician on the basis of the child's nonverbal behavior.
Items scales are 1 to 5 for sleep, appetite, and speech and 1 to 7 for the remaining 14 items.
Total scores are summed and range from 17 to 113, with lower scores indicating normality while higher scores indicate psychopathology.
Lower scores post-intervention indicate treatment efficacy.
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Baseline and 16-weeks
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CGAS Score
Periodo de tiempo: Baseline and 16-weeks
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The Children's Global Assessment Scale (CGAS) is a numeric scale used by mental health clinicians to rate the general functioning.
Scores range from 1 to 100, with high scores indicating better functioning.
A score of 1-10 indicates the need for constant supervision, while a score of 91-100 indicates superior functioning.
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Baseline and 16-weeks
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SAS-SR Score
Periodo de tiempo: Baseline and 16-weeks
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The SAS-SR provides an understanding of an individual's level of satisfaction with his or her social situation, measuring the level of both behavioral and emotional social adjustment across four major areas (school, friends, family, and dating).
Participants answer each item on a scale of 1 to 5. The total score also ranges from 1 to 5 and is the average of all item scores.
The total score provides an index of social impairment with higher mean score indicating more difficulties with social adjustment.
Lower scores post treatment indicate efficacy of the intervention.
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Baseline and 16-weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Meredith Gunlicks-Stoessel, PhD, University of Minnesota
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2010
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
1 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
27 de febrero de 2013
Publicado por primera vez (Estimar)
1 de marzo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2019
Última verificación
1 de julio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Síntomas de comportamiento
- Desordenes mentales
- Trastornos del estado de ánimo
- Depresión
- Desorden depresivo
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Drogas psicotropicas
- Inhibidores de la captación de serotonina
- Inhibidores de la captación de neurotransmisores
- Moduladores de transporte de membrana
- Agentes de serotonina
- Agentes antidepresivos
- Inhibidores de enzimas del citocromo P-450
- Agentes antidepresivos, segunda generación
- Inhibidores del citocromo P-450 CYP2D6
- Fluoxetina
Otros números de identificación del estudio
- 1110M05542
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. .