Advertisement

Topics

Adjunctive Pregnenolone in Veterans With Mild TBI

2014-08-27 03:32:39 | BioPortfolio

Summary

Mild traumatic brain injury (TBI) is common among veterans who have served in OEF/OIF (Operation Enduring Freedom in Afghanistan/Operation Iraqi Freedom) and other theatres. Delayed symptoms may occur following TBI, including cognitive symptoms (impaired attention, processing speed, executive functioning), as well as behavioral symptoms such as anxiety, depression, and irritability (Fann et al. 2004; Holsinger et al. 2002). Neuroactive steroids have neuroprotective effects in rodent models of TBI (Djebaili et al. 2005; Djebaili et al. 2004; He et al. 2004; Pettus et al. 2005; Roof et al. 1997) and the neuroactive steroid pregnenolone and its sulfated derivative also markedly enhance learning and memory in rats (Akwa et al. 2001; Flood et al. 1992; Flood et al. 1995; Vallee et al. 1997; Vallee et al. 2003). In humans, reductions in pregnenolone (George et al. 1994) and its GABAergic metabolite allopregnanolone (Uzunova et al. 1998) have been associated with depressive symptoms. Pharmacological intervention with the neuroactive steroid pregnenolone could therefore result in a multi-targeted treatment approach, potentially improving cognitive deficits as well as anxiety and depression symptoms following TBI.

Description

See brief summary

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Traumatic Brain Injury

Intervention

Pregnenolone, Placebo

Location

Durham VA Medical Center
Durham
North Carolina
United States
27705

Status

Recruiting

Source

Durham VA Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:39-0400

Clinical Trials [1875 Associated Clinical Trials listed on BioPortfolio]

Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

The study will explore the neurocognitive effect of four weeks of treatment with amantadine versus placebo in patients with traumatic brain injury using the Interval Bisection Timing Task....

Traumatic Brain Injury and Effects of Acute Cyclosporine A

This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for other...

Adjunctive Pregnenolone in Post-Traumatic Stress Disorder (PTSD) and Depression in Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans

This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.

Progesterone for the Treatment of Traumatic Brain Injury

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims ...

Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder

The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are ...

PubMed Articles [12029 Associated PubMed Articles listed on BioPortfolio]

Predictors of Employment Outcomes in Veterans With Traumatic Brain Injury: A VA Traumatic Brain Injury Model Systems Study.

To examine the length of time to return to work (RTW) among service members and veterans (SM/V) with traumatic brain injury (TBI) and to identify variables predictive of RTW.

Neurobehavioral Management of Traumatic Brain Injury in the Critical Care Setting: An Update.

Traumatic brain injury (TBI) is an alteration in brain function, or other evidence of brain pathology, caused by an external force. TBI is a major cause of disability and mortality worldwide. Post-tra...

Sertraline for Major Depression During the Year Following Traumatic Brain Injury: A Randomized Controlled Trial.

Major depressive disorder (MDD) is common and associated with impaired functioning after traumatic brain injury (TBI). Few placebo-controlled antidepressant trials exist in this population. We evaluat...

Early Systolic Dysfunction Following Traumatic Brain Injury: A Cohort Study.

Prior studies have suggested that traumatic brain injury may affect cardiac function. Our study aims were to determine the frequency, longitudinal course, and admission risk factors for systolic dysfu...

Expression of masculine identity in individuals with a traumatic brain injury.

This research seeks to examine and describe how four males with a traumatic brain injury (TBI) use language to negotiate their masculine identities.

Medical and Biotech [MESH] Definitions

Prolonged unconsciousness from which the individual cannot be aroused, associated with traumatic injuries to the BRAIN. This may be defined as unconsciousness persisting for 6 hours or longer. Coma results from injury to both cerebral hemispheres or the RETICULAR FORMATION of the BRAIN STEM. Contributing mechanisms include DIFFUSE AXONAL INJURY and BRAIN EDEMA. (From J Neurotrauma 1997 Oct;14(10):699-713)

A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain.

Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.

Traumatic injuries to the cranium where the integrity of the skull is not compromised and no bone fragments or other objects penetrate the skull and dura mater. This frequently results in mechanical injury being transmitted to intracranial structures which may produce traumatic brain injuries, hemorrhage, or cranial nerve injury. (From Rowland, Merritt's Textbook of Neurology, 9th ed, p417)

Bleeding within the brain as a result of penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA. Traumatically induced hemorrhages may occur in any area of the brain, including the CEREBRUM; BRAIN STEM (see BRAIN STEM HEMORRHAGE, TRAUMATIC); and CEREBELLUM.

More From BioPortfolio on "Adjunctive Pregnenolone in Veterans With Mild TBI"

Quick Search
Advertisement
 

Relevant Topics

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...


Searches Linking to this Trial