Depression Clinical Trial
Official title:
The Use of Non Invasive Brain Stimulation in the Treatment of the Sequelae of Closed Brain Injury
NCT number | NCT00531258 |
Other study ID # | 011007 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2008 |
Est. completion date | May 2015 |
Verified date | October 2020 |
Source | Bayside Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Depression is very common in people who have experienced a traumatic brain injury. Few treatments have been found to be effective in treating depression in this situation. We intend to investigate the effectiveness of a form of brain stimulation, transcranial magnetic stimulation, which has been found to be effective in treating depression in people who have not undergone a brain injury. By evaluating new methods of treating depression in this population, we hope to increase the options available for treating people in this difficult situation. Furthermore, problems with aspects of thinking are also commonly present post brain injury, as in some individuals with depression. Various brain stimulation techniques, including transcranial magnetic stimulation (TMS) have been shown to have a positive effect on cognition. We also intend to investigate whether a therapeutic effect on cognitive deficits is present following TMS, in addition to any effects on depression. New treatment protocols will be developed, and understanding of the pathology and treatment of post traumatic brain injury depression will be enhanced.
Status | Completed |
Enrollment | 21 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion criteria: 1. Be aged 18-60 and have capacity to consent 2. Currently meet DSM-IV criteria for a diagnosis of major depressive disorder (expect for the exclusion of causality by a general medical condition referring to the TBI) and have the persistence of depressive symptoms for at least one month at sufficient severity to warrant the diagnosis. 3. Have experienced a closed head injury of mild to moderate severity (Glasgow coma scale score (GCS) of greater than 8), preceding their depression, and are at least 3 months post injury. The injury must not have involved specific direct damage to either frontal lobe. 4. Have a Montgomery Asberg Rating Scale Score of > 20 (moderate - severe depression). Including only a more severely ill group of subjects limits the placebo response rate. 5. Have had no increase or initiation of new antidepressant (or other psychoactive) therapy in the 4 weeks prior to enrolment. Exclusion Criteria: 1. Patients who have an unstable medical condition, neurological disorder or any history of a seizure disorder or are currently pregnant or lactating. 2. Patients who have experienced clear structural damage to the left or right dorsolateral prefrontal cortex as documented on MRI scan 3. Have a current DSM IV diagnosis of alcohol or substance dependence disorder. |
Country | Name | City | State |
---|---|---|---|
Australia | Alfred Psychiatry Research Centre | Prahran | Victoria |
Lead Sponsor | Collaborator |
---|---|
Bayside Health |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Depression Symptom Severity | 4 weeks | ||
Secondary | Cognitive Tasks | 4 Weeks |
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