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

6. september 2012 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Colorado
      • Denver, Colorado, Forente stater, 80220
        • Rekruttering
        • Denver Veteran's Affairs Medical Center
        • Ta kontakt med:
          • Brandon Schmidt, MA
          • Telefonnummer: 720-854-4200

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: sukkerpille
Aktiv komparator: divalproex natrium

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduced Affective Lability
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Reduced Alcohol Use
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2009

Primær fullføring (Forventet)

1. mai 2013

Studiet fullført (Forventet)

1. desember 2013

Datoer for studieregistrering

Først innsendt

29. mars 2011

Først innsendt som oppfylte QC-kriteriene

30. mars 2011

Først lagt ut (Anslag)

31. mars 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

7. september 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. september 2012

Sist bekreftet

1. september 2012

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PT075168 (Annen identifikator: Department of Defense)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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