Biomarkers for Outcomes In Late-life Depression (BOLD)
| Status: | Completed |
|---|---|
| Conditions: | Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 62 - Any |
| Updated: | 3/30/2013 |
| Start Date: | October 2009 |
| End Date: | October 2012 |
| Contact: | Jennifer Villalobos |
| Email: | jpv@brain.ucla.edu |
| Phone: | 310-825-0248 |
Biomarkers for Outcomes In Late-life Depression
Major depressive disorder (MDD) is a common psychiatric illness with high cost to society
and individual patients. One reason for the high cost is that most patients endure lengthy
and ultimately unsuccessful empiric antidepressant trials before a successful medication is
identified by trial-and-error. Care would be improved if a biomarker could determine, early
in the course of treatment, whether a particular antidepressant would likely lead to
response, remission, or treatment failure. Physicians could rapidly change treatments to an
antidepressant which the biomarker indicated would be likely to help the patient. We have
identified quantitative electroencephalographic (QEEG) changes that emerge early in the
course of treatment with selective serotonin reuptake inhibitors (SSRIs) that appear to
predict later response and remission in a general adult patient population. Demographic
trends in the United States suggest that improved care for MDD will be essential for a
growing number of elderly with late-life depression. While the consequences of prolonged
trial-and-error periods to find a successful treatment are particularly inauspicious for
elders with late-life depression, this patient group has not been included in the past
studies which demonstrated the use of this biomarker approach in a general adult population.
We propose a 12-week treatment trial to evaluate a practical biomarker for predicting
outcome based on data from the first week of antidepressant treatment, with a focus only on
depression in late life (age ≥65).
There are three study Hypothesis:
H1) ATR prediction of treatment outcome in older subjects will show >70% accuracy.
H2) The predictive accuracy of the model will be enhanced by including clinical,
socio-demographic, and genetic predictors.
H3) The accuracy of ATR prediction will not show a significant dependence on subject gender.
Inclusion Criteria:
- 62 years of age or older
- Meet the DSM-IV diagnosis of MDD based on Sheehan's Mini-International
Neuropsychiatric Interview (MINI), with a score of > 28 on the 30-item Inventory of
Depressive Symptomatology - Self Rated version (IDS-SR30)
Exclusion Criteria:
- Subjects will have no unstable medical illness that would prevent completion of
participation in the trial, determined as needed from physical examination, ECG,
laboratory safety tests, as well as a review of systems
- mentally or legally incapacitated, unable to give informed consent
- meets DSM-IV criteria for anorexia nervosa, bulimia nervosa, obsessive-compulsive
disorder, any cognitive disorder, bipolar disorder, psychotic disorder, or major
depression with psychotic features
- MMSE (Folstein et al., 1975) score ≤ 24
- evidence of drug dependency or substance abuse within the preceding nine months
- stable and in remission on current psychotropic medication(s)
- any ECT within the past six months
- failure to tolerate ESC or treatment failure with an adequate trial of ESC in the
current episode
- ESC would be contraindicated (e.g., hyponatremia with a prior SSRI)
- treatment with fluoxetine or an MAOI within the past four weeks
- any medical illness severe enough to significantly affect brain function or to
interfere with interpretation of study results
- history of seizures, brain surgery, skull fracture, significant head trauma, or
abnormal EEG
- psychiatric hospitalization indicated (e.g., imminent danger to self or others)
- initial QEEG recording is contaminated with artifact so that determination of the
biomarker is precluded
- use of medications known to affect brain function (e.g., antidepressants,
anticonvulsants/mood stabilizers, anticholinergics, antipsychotics, benzodiazepines -
same list as in BRITE-MD)
We found this trial at
1
site
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