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Divalproex Sodium for Mood Swings and Alcohol Use Following Head Injury.

6 de septiembre de 2012 actualizado por: Paul Saenger

A Double Blind Trial Of Divalproex Sodium For Affective Lability And Alcohol Use Following Traumatic Brain Injury

Despite the body's natural healing during the first year after a head injury, many veterans who have suffered even mild brain injuries find themselves easily upset or fearful as they go about their daily lives. While these reactions to the world around them were easily managed before the head injury, they now occur with little or no interruption and are exceedingly difficult to manage. Such reactions include a sense of always being upset or fearful that often makes it difficult to get along with family members, friends, coworkers, and employers. This may lead to broken marriages, unemployment, and even homelessness.

Some people with head injuries try to manage their unmanageable moods by drinking alcohol because it can create a sense of calm. However, alcohol's actions are short in duration. Most find that they have to drink more and more for a similar calming effect, and they soon become dependent on alcohol. This makes working and being part of their families even more difficult.

To treat the unmanageable mood, we tried a medicine called valproate, one that eases mood problems in people without head injury. We gave valproate to head injured persons with mood problems in a "non-blinded" study where both the doctor and the patient knew that the medicine was valproate and both were optimistic that it would work. In a small sample of eighteen people, 85% found mood relief and most of those either stopped drinking alcohol or drank much less than before. However, this might have been because both the doctor and patient were hopeful that the medication would make the patient feel better or because the medicine actually worked.

The only way to know for sure if the medicine works is to perform a study in which people receive either valproate or a sugar pill while neither they nor their doctor know which one they are taking. This is called a double blind study, as proposed here, and will involve nearly three times as many head injured persons as the first study.

If it is successful, this study will show that valproate treatment helps head injured people manage their moods and allows them to return to families, friends, and work. It will also show that they drink alcohol less or not at all, improving their health even further. Then doctors will know that they can use this medicine for large numbers of people who suffer from head injury and help them to lead normal lives. If the outcome of the study shows that the medicine works well, doctors can then use this medicine to treat people with head injury immediately after the study results are published.

Descripción general del estudio

Estado

Desconocido

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

50

Fase

  • No aplica

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

    • Colorado
      • Denver, Colorado, Estados Unidos, 80220
        • Reclutamiento
        • Denver Veteran's Affairs Medical Center
        • Contacto:
          • Brandon Schmidt, MA
          • Número de teléfono: 720-854-4200

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

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • a history of remote (≥ 1 year prior to study enrollment) non-penetrating TBI
  • currently using alcohol
  • symptoms of affective lability: mood swings, irritability, frustration

Exclusion Criteria:

  • a history of bipolar disorder or anxiety disorder prior to any head injury
  • a history of head injury in which the cranium was opened either traumatically or surgically
  • a history of stroke
  • a history of seizure disorder other than those caused by ethanol withdrawal
  • evidence of active liver disease
  • current diagnosis or past history of major psychosis, the alcohol amnesic syndrome, or any type of dementia
  • current suicidal/homicidal ideations
  • any medical conditions that would constitute contraindications to treatment with divalproex sodium
  • currently taking any medications that are known to affect the metabolism of divalproex sodium

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: pastilla de azúcar
Comparador activo: divalproato de sodio

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduced Affective Lability
Periodo de tiempo: Study weeks 1-10
The primary analysis addresses our primary hypothesis that treatment with divalproex sodium will lessen affective lability significantly (p<0.05) as compared to placebo. We will characterize affective lability using discrete variables of presence or extent of symptoms yielded by the Neurobehavioral Rating Scale-Revised (Levin et al., 1990) as well as eight target items from the Agitated Behavior Scale (Bogner et al., 2000). Average intensity and duration of affective lability will be compared between groups.
Study weeks 1-10

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reduced Alcohol Use
Periodo de tiempo: Study weeks 1-10
The secondary analysis first addresses our secondary hypothesis that treatment with divalproex sodium will lessen quantity and frequency of ethanol use significantly (p<0.05) as compared to placebo in a sample of TBI subjects. We will characterize drinking using the Time Line Follow-Back for Drugs and Alcohol method, developed by Sobell et al (Sobell et al., 1979).
Study weeks 1-10

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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 octubre de 2009

Finalización primaria (Anticipado)

1 de mayo de 2013

Finalización del estudio (Anticipado)

1 de diciembre de 2013

Fechas de registro del estudio

Enviado por primera vez

29 de marzo de 2011

Primero enviado que cumplió con los criterios de control de calidad

30 de marzo de 2011

Publicado por primera vez (Estimar)

31 de marzo de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

7 de septiembre de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

6 de septiembre de 2012

Última verificación

1 de septiembre de 2012

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PT075168 (Otro identificador: Department of Defense)

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. .

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