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NCT01760785 · ClinicalTrials.gov registry record · NA
Valproate for Mood Swings and Alcohol Use Following Head Injury
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT01760785: Completed NA study, sponsored by University of Colorado, Denver.
NCT01760785 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01760785, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective lability following TBI. Observed clinically, the symptoms of poorly regulated affective expression of AA/D+TBI patients who reach alcohol abstinence do not appear to be those of an idiopathic mood or anxiety disorder. These symptoms do not present the severity or the same natural courses as do Major Depressive Disorder, Bipolar Illness, or Anxiety Disorder, for example. Instead, both symptoms and course appear more characteristic of the sustained affect lability often observed following TBI. This observation suggests that TBI survivors represent a patient group for whom treatment of neuropsychiatric symptoms following TBI may alleviate both TBI-related affect lability and also heavy ethanol use by treating the condition that is contextually related to excessive alcohol use. Based on this concept of consequently treating AA/D through the management of post-TBI affective lability, this study was conducted observing the efficacy of divalproex sodium on the severity of affective lability and AA/D in persons suffering from a moderate TBI. Divalproex sodium has been shown to ameliorate mood disorders, even in those with substance abuse problems. This drug has also shown positive results as an alternate medication to benzodiazapines in the treatment of alcohol withdrawal, significantly reducing the progression of withdrawal symptoms in patients.
Primary Outcome
Severity of affective lability was measured using a shortened version of the Agitated Behavior Scale (ABS). The ABS is used to assess the nature and extent of present agitation. Eight items from the 14-item scale were used, which measured the presence and severity of various affective lability symptoms including: short attention span, impulsivity, uncooperative behavior, violent tendencies, restlessness, rapid or excessive talking, sudden changes in mood, and easily initiated or excessive crying
Interventions
- DRUG Placebo
- DRUG divalproex sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-09 |
| Est. Completion | 2016-06 |
| Phase | NA |
What the finished NCT01760785 record still lists
NCT01760785 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01760785 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01760785 about?
NCT01760785 is a clinical study titled "Valproate for Mood Swings and Alcohol Use Following Head Injury". Successful treatment of traumatic brain injury (TBI)-induced mood lability may reduce or eliminate drinking behaviors in persons with alcohol abuse/dependence (AA/D) and affective lability following TBI. Observed clinically, the symptoms of poorly regulated affective expression of AA/D+TBI patients ...
What is the current status of trial NCT01760785?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2008-09. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01760785?
The interventions under investigation include: Placebo (DRUG), divalproex sodium (DRUG).
Who is sponsoring clinical trial NCT01760785?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01760785's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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